{"registry": "ISRCTN", "registryId": "ISRCTN83842641", "source": "https://www.isrctn.com/ISRCTN83842641", "apiSource": "https://www.isrctn.com/api/trial/ISRCTN83842641/format/default", "fetchedAt": "2026-10-07T17:00:59.154824Z", "license": "CC BY 4.0", "licenseSource": "https://www.isrctn.com/page/faqs#licence-to-post", "study": {"title": "A trial assessing preoperative chemotherapy in patients with locally advanced but operable colon cancer", "scientificTitle": "FOxTROT: personalising neo-adjuvant chemotherapy in locally advanced but operable colon cancer", "acronym": "FOxTROT", "hypothesis": "The overall aim of the FOxTROT trial platform is to refine and personalise the use of the neoadjuvant chemotherapy pathway in locally advanced operable colon cancer. As well as testing new clinical hypotheses within the platform, molecular stratification from diagnostic tissue will create future opportunities to test targeted novel agents with proven efficacy and safety in colon cancer.\n\nFOxTROT 2: The alternative hypothesis is that the proportion of patients alive and disease-free at 3 years after randomisation treated with neoadjuvant chemotherapy (OxFp) is superior compared to those going straight to surgery. The null hypothesis in that there is no difference is the proportion of patients alive and disease-free at 3 years after randomisation.\n\nFOxTROT 3: The alternative hypothesis is that the distribution of the tumour regression grade at the time of surgery allocated to mFOLFOXIRI is superior compared to those allocated to OxFp. The null hypothesis in that there is no difference in tumour regression grade (TRG).\n\n(added 17/10/2023):\nFOxTROT 4: The alternative hypothesis is that 6 weeks of neoadjuvant treatment with the EC doublet will be safe and result in significant tumour regression compared with 6 weeks of neoadjuvant oxaliplatin and fluoropyrimidine (OxFp) chemotherapy.\n\n(added 14/08/2024)\nFOxTROT 5: The alternative hypothesis is that in older and/or frail patients with untreated locally advanced dMMR/MSI-H CC, 12 weeks of neoadjuvant dostarlimab (an anti-PD1 monoclonal antibody) prior to surgery with curative intent, followed by 36 weeks of post-operative dostarlimab, will demonstrate similar efficacy to that seen in younger and fitter populations.", "primaryOutcome": "FOxTROT 2: Disease-free survival (DFS), defined as the time from randomisation to disease recurrence, treatment failure, or death from any cause. The date of recurrence will be taken as the date of the CT scan which concluded disease recurrence. If a CT scan is not carried out, the date of recurrence will be taken as the date of the sample which indicated disease recurrence. Individuals who are lost to follow-up or are alive and disease-free at the time of analysis will be censored at their last date known to be alive and disease-free.\n\nFOxTROT 3: Tumour regression grade (TRG) (categorised as no response, mild, moderate, marked and complete response), measured at the time of surgery according to the modified Dworak grading system. DFS will be defined as per the FOxTROT 2 primary endpoint.\n\n(added 17/10/2023)\nFOxTROT 4: Tumour regression grade (TRG) categorised as response or no response, measured at the time of surgery according to the modified Dworak grading system, where response includes the subcategories mild, moderate, marked and complete response.\n\n(added 14/08/2024)\nFOxTROT 5: Proportion of participants with a pathological complete response in the resected tumour following neoadjuvant dostarlimab.", "secondaryOutcome": "Current secondary outcome measures as of 14/08/2024:\n\nApplicable to FOxTROT 2, FOxTROT 3, FOxTROT 4 and FOxTROT 5, where not part of the primary outcome measures:\n1. Tumour regression grade (TRG) measured according to the modified Dworak grading system at the time of surgery\n2. Tumour regression score (TRS) (categorised as poor/no response, partial, near complete and complete response), measured at the time of surgery\n3. Histopathological endpoints, measured from pathological samples at the time of surgery:\n3.1. Tumour cell density\n3.2. Maximum tumour size\n3.3. Depth of invasion\n3.4. Apical node involvement\n3.5. Peritoneal involvement\n3.6. Nodal involvement\n3.7. R1/R2 resection rates\n4 Short-term efficacy (and association with longer-term outcomes):\n4.1. Downstaging by T-stage, measured at pre-registration, post- neoadjuvant treatment (NAT) and 3-years post randomisation\n4.2. Minimal residual disease by ctDNA and ctDNA alterations during NAT measured from blood samples collected at baseline, prior to each cycle of NAT, post-NAT and prior to adjuvant therapy\n5. Safety and toxicity (treatment related) defined as the adverse reactions (ARs or irARs) and serious adverse events (SAEs) (including serious adverse reactions (SARs) and serious unexpected serious adverse reactions (SUSARs)) reported on the trial according to CTCAE v5.0 and Clavien-Dindo.\n6. Cancer-related survival, defined as the time from randomisation to death caused by the same cancer, whether due to the original tumour or to a second primary same cancer. Individuals who are lost to follow-up or are still alive at the time of analysis will be censored at their last date known to be alive. Death not related to cancer will be specified as a competing risk.\n7. Overall survival, defined as the time from randomisation to death from any cause. Individuals who are lost to follow-up or are still alive at the time of analysis will be censored at their last date known to be alive.\n8. Surgical morbidity, defined as any surgery-related complication within 30 days post-surgery and surgical mortality, defined as death from any cause within 30 days post-surgery.\n9. Patient-reported outcomes (PROs) assessed according to outcomes measured on the EQ-5D5L and QLQ-C30 and CR29. PROs will be collected at timepoints defined according to the protocol.\n10. Geriatric assessment scoring, will be determined by the collection of domains used to assess frailty, full details of which are provided in the FOxTROT 2 protocol. Geriatric assessment data will be collected at baseline, and prior to adjuvant treatment – FOxTROT 2 and FOxTROT 5 only\n11. Disease-free survival (DFS)\n\n_______\n\nPrevious secondary outcome measures as of 17/10/2023 to 14/08/2024: \n1. Tumour regression grade (TRG) measured according to the modified Dworak grading system at the time of surgery – FOxTROT 2 only\n2. Tumour regression score (TRS) (categorised as poor/no response, partial, near complete and complete response), measured at the time of surgery – FOxTROT 2, FOxTROT 3 & FOxTROT 4\n3. Histopathological endpoints, measured from pathological samples at the time of surgery – FOxTROT 2, FOxTROT 3 & FOxTROT 4:\n3.1. Tumour cell density\n3.2. Maximum tumour size\n3.3. Depth of invasion\n3.4. Apical node involvement\n3.5. Peritoneal involvement\n3.6. Nodal involvement\n3.7. R1/R2 resection rates\n4. Short-term efficacy (and association with longer-term outcomes) – FOxTROT 2, FOxTROT 3 and FOxTROT 4:\n4.1. Downstaging by T-stage, measured at pre-registration, post-NAC and 3-years postrandomisation\n4.2. Minimal residual disease by ctDNA and ctDNA alterations during neoadjuvant chemotherapy (NAC), measured from blood samples collected at baseline, prior to each cycle of NAC, post-NAC and prior to adjuvant chemotherapy\n5. Safety and toxicity (both surgical and chemotherapy-related) defined as the adverse reactions (ARs) and serious adverse events (SAEs) (including serious adverse reactions (SARs) and serious unexpected serious adverse reactions (SUSARs)) reported on the trial according to CTCAE v5.0 and Clavien-Dindo – FOxTROT 2, 3 and 4\n6. Cancer-related survival, defined as the time from randomisation to death caused by the same cancer, whether due to the original tumour or to a second primary same cancer. Individuals who are lost to follow-up or are still alive at the time of analysis will be censored at their last date known to be alive. Death not related to cancer will be specified as a competing risk – FOxTROT 2, FOxTROT 3 and FOxTROT 4\n7. Overall survival, defined as the time from randomisation to death from any cause. Individuals who are lost to follow-up or are still alive at the time of analysis will be censored at their last date known to be alive – FOxTROT 2, FOxTROT 3 and FOxTROT 4\n8. Surgical morbidity, defined as any surgery-related complication within 30 days post-surgery and surgical mortality, defined as death from any cause within 30 days post-surgery – FOxTROT 2, FOxTROT 3 and FOxTROT 4\n9. Patient-reported outcomes (PROs) assessed according to outcomes measured on the EQ-5D5L and QLQ-C30 and CR29. PROs will be collected at baseline, post-NAC, prior to adjuvant chemotherapy, 12 months post-randomisation and 3 years post-randomisation – FOxTROT 2,\n10. Geriatric assessment scoring, will be determined by the collection of domains used to assess frailty, full details of which are provided in the FOxTROT 2 protocol. Geriatric assessment data will be collected at baseline, and prior to adjuvant chemotherapy – FOxTROT 2 only\n11. Disease-free survival (DFS) – FOxTROT 4\n\n_____\n\nPrevious secondary outcome measures:\n\n1. Tumour regression grade (TRG) measured according to the modified Dworak grading system at the time of surgery – FOxTROT 2 only\n2. Tumour regression score (TRS) (categorised as poor/no response, partial, near complete and complete response), measured at the time of surgery – FOxTROT 2&3\n3. Histopathological endpoints, measured from pathological samples at the time of surgery – FOxTROT 2&3:\n3.1. Tumour cell density\n3.2. Maximum tumour size\n3.3. Depth of invasion\n3.4. Apical node involvement\n3.5. Peritoneal involvement\n3.6. Nodal involvement\n3.7. R1/R2 resection rates\n4. Short-term efficacy (and association with longer-term outcomes) – FOxTROT 2 & 3:\n4.1. Downstaging by T-stage, measured at pre-registration, post-NAC and 3-years post-randomisation\n4.2. Minimal residual disease by ctDNA and ctDNA alterations during neoadjuvant chemotherapy (NAC), measured from blood samples collected at baseline, prior to each cycle of NAC, post-NAC and prior to adjuvant chemotherapy\n5. Safety and toxicity (both surgical and chemotherapy-related) defined as the adverse reactions (ARs) and serious adverse events (SAEs) (including serious adverse reactions (SARs) and serious unexpected serious adverse reactions (​SUSARs)) reported on the trial according to CTCAE v5.0 and Clavien-Dindo – FOxTROT 2 & 3\n6. Cancer-related survival, defined as the time from randomisation to death caused by the same cancer, whether due to the original tumour or to a second primary same cancer. Individuals who are lost to follow-up or are still alive at the time of analysis will be censored at their last date known to be alive. Death not related to cancer will be specified as a competing risk – FOxTROT 2 & 3\n7. Overall survival, defined as the time from randomisation to death from any cause. Individuals who are lost to follow-up or are still alive at the time of analysis will be censored at their last date known to be alive – FOxTROT 2 & 3\n8. Surgical morbidity, defined as any surgery-related complication within 30 days post-surgery and surgical mortality, defined as death from any cause within 30 days post-surgery – FOxTROT 2 & 3\n9. Patient-reported outcomes (PROs) assessed according to outcomes measured on the EQ-5D-5L and QLQ-C30 and CR29. PROs will be collected at baseline, post-NAC, prior to adjuvant chemotherapy, 12 months post-randomisation and 3 years post-randomisation – FOxTROT 2 & 3 \n10. Geriatric assessment scoring, will be determined by the collection of domains used to assess frailty, full details of which are provided in the FOxTROT 2 protocol. Geriatric assessment data will be collected at baseline, and prior to adjuvant chemotherapy – FOxTROT 2 only", "intervention": "\n\tCurrent interventions as of 14/08/2024:\n\nFOxTROT is a stratified, multi-arm, multi-site randomised trial platform for patients with locally advanced but operable colon cancer. Prior to the initial registration period, all patients will have been assessed at a colon cancer MDT for review of pathology and radiology and potential participants will be identified. Patients meeting the registration eligibility criteria will be registered and a decision will be made about which FOxTROT comparison is most suitable. Participants will then be randomised in the appropriate comparison.\n\nFOxTROT 2 randomises participants between two trial arms:\n1. Straight to surgery: patients will proceed straight to surgery as soon as possible and will be assessed for adjuvant chemotherapy as standard care.\n2. Neoadjuvant chemotherapy followed by surgery. Participants in this arm will receive 6 weeks of OxFP chemotherapy with a choice (non-randomised) between two regimens: OxMdG (2-weekly oxaliplatin/calcium folinate/infusional fluorouracil) or OxCap (3-weekly oxaliplatin with capecitabine). These should be delivered as per local practice. The clinician has two options of initial dosing as described above: full dose OxFp, or 80% dose OxFp. Treatment should start as soon as possible following randomisation. Patients should be reviewed prior to each cycle of treatment to assess for toxicity and any evidence of disease progression.\nFollowing the completion of neoadjuvant chemotherapy, all participants will be reviewed in the oncology clinic to be assessed for adjuvant chemotherapy.\n\nFOxTROT 3 randomises participants between two trial arms:\n1. In the control arm, Neoadjuvant chemotherapy (NAC) consists of 6 weeks of standard OxFp with a choice (non-randomised) of either OxMdG (2-weekly oxaliplatin/calcium folinate/infusional fluorouracil) or OxCap (3-weekly oxaliplatin with capecitabine).\n2. In the experimental arm, NAC comprises three 2-weekly cycles of mFOLFOXIRI (oxaliplatin, irinotecan, calcium folinate, then a 46-hour infusion of fluorouracil).\n\nFor both arms, treatment should start as soon as possible following randomisation. Patients will receive postoperative adjuvant chemotherapy (AC) of either 6 or 18 weeks, bringing the total NAC/AC duration to 3 or 6 months respectively. In the control arm, AC is with OxFp; in the experimental arm AC may be either mFOLFOXIRI or OxFp.\n\nFOxTROT 4 randomises participants between two trial arms:\n1. In the control arm, NAC consists of 6 weeks of standard OxFp with a choice (non-randomised) of either OxMdG (2-weekly oxaliplatin/calcium folinate/infusional fluorouracil) or OxCap (oxaliplatin and capecitabine).\n2. In the experimental arm, Neoadjuvant systemic anti-cancer therapy (NA SACT) comprises three 2-week cycles of cetuximab and encorafenib once daily (EC). Treatment should start as soon as possible following randomisation. Postoperative adjuvant treatment will be as per local practice.\n\nFOxTROT 5 is a single-arm study and all participants will receive 12 weeks (a maximum of four, 3-weekly cycles; 500 mg IV on day 1 of each cycle) of preoperative dostarlimab and 36 weeks (a maximum of six, 6-weekly cycles; 1000 mg IV on day 1 of each cycle) of postoperative dostarlimab. Treatment should start as soon as possible following enrolment.\n\nParticipants will be randomised or enrolled using a central automated 24-hour internet service based at the Leeds Clinical and Translational Research Unit (CTRU).\n_____\n\nPrevious interventions as of 17/10/2023: \n\nFOxTROT is a stratified, multi-arm, multi-site randomised trial platform for patients with locally advanced but operable colon cancer. Prior to the initial registration period, all patients will have been assessed at a colon cancer MDT for review of pathology and radiology and potential participants will be identified. Patients meeting the registration eligibility criteria will be registered and a decision will be made about which FOxTROT comparison is most suitable. Participants will then be randomised in the appropriate comparison.\n\nFOxTROT 2 randomises participants between two trial arms:\n1. Straight to surgery: patients will proceed straight to surgery as soon as possible and will be assessed for adjuvant chemotherapy as standard care. \n2. Neoadjuvant chemotherapy followed by surgery. Participants in this arm will receive 6 weeks of OxFP chemotherapy with a choice (non-randomised) between two regimens: OxMdG (2-weekly oxaliplatin/calcium folinate/infusional fluorouracil) or OxCap (3-weekly oxaliplatin with capecitabine). These should be delivered as per local practice. The clinician has two options of initial dosing as described above: full dose OxFp, or 80% dose OxFp. Treatment should start as soon as possible following randomisation. Patients should be reviewed prior to each cycle of treatment to assess for toxicity and any evidence of disease progression.\nFollowing the completion of neoadjuvant chemotherapy, all participants will be reviewed in the oncology clinic to be assessed for adjuvant chemotherapy.\n\nFOxTROT 3 randomises participants between two trial arms:\n1. In the control arm, Neoadjuvant chemotherapy (NAC) consists of 6 weeks of standard OxFp with a choice (non-randomised) of either OxMdG (2-weekly oxaliplatin/calcium folinate/infusional fluorouracil) or OxCap (3-weekly oxaliplatin with capecitabine).\n2. In the experimental arm, NAC comprises three 2-weekly cycles of mFOLFOXIRI (oxaliplatin, irinotecan, calcium folinate, then a 46-hour infusion of fluorouracil).\n\nFor both arms, treatment should start as soon as possible following randomisation. Patients will receive postoperative adjuvant chemotherapy (AC) of either 6 or 18 weeks, so bringing the total NAC/AC duration to 3 or 6 months respectively. In the control arm, AC is with OxFp; in the experimental arm AC may be either mFOLFOXIRI or OxFp.\n\nFOxTROT 4 randomises participants between two trial arms:\n1. In the control arm, NAC consists of 6 weeks of standard OxFp with a choice (non-randomised) of either OxMdG (2-weekly oxaliplatin/calcium folinate/infusional fluorouracil) or OxCap (oxaliplatin and capecitabine).\n2. In the experimental arm, Neoadjuvant systemic anti-cancer therapy (NA SACT) comprises three 2-week cycles of cetuximab and encorafenib once daily (EC). Treatment should start as soon as possible following randomisation. Postoperative adjuvant treatment will be as per local practice.\n\nParticipants will be randomised using a central automated 24-hour internet service based at the Leeds Clinical and Translational Research Unit (CTRU).\n\n_____\n\nPrevious interventions:\n\nFOxTROT is a stratified, multi-arm, multi-site randomised trial platform for patients with locally advanced but operable colon cancer. All patients will have been assessed at a colon cancer MDT for review of pathology and radiology and potential participants will be identified. Patients meeting the registration eligibility criteria will be registered and a decision will be made about which FOxTROT comparison is most suitable. Participants will then be randomised in the appropriate comparison.\n\nFOxTROT 2 randomises participants between two trial arms:\n1. Straight to surgery: patients will proceed straight to surgery as soon as possible and will be assessed for adjuvant chemotherapy as standard care. \n2. Neoadjuvant chemotherapy followed by surgery. Participants in this arm will receive 6 weeks of OxFP chemotherapy with a choice (non-randomised) between two regimens: OxMdG (2-weekly oxaliplatin/calcium folinate/infusional fluorouracil) or OxCap (3-weekly oxaliplatin with capecitabine). These should be delivered as per local practice. The clinician has two options of initial dosing as described above: full dose OxFp, or 80% dose OxFp. Treatment should start as soon as possible following randomisation. Patients should be reviewed prior to each cycle of treatment to assess for toxicity and any evidence of disease progression.\n\nFollowing the completion of neoadjuvant chemotherapy, all participants will be reviewed in the oncology clinic to be assessed for adjuvant chemotherapy.\n\nParticipants will be randomised using a central automated 24-hour internet service based at the Leeds Clinical and Translational Research Unit (CTRU).\n\tDrug\n\tPhase II/III\n\tFOxTROT 2: Oxaliplatin, calcium folinate, infusional fluorouracil, capecitabine; FOxTROT 3: Irinotecan, Oxaliplatin, calcium folinate, Fluorouracil, Capecitabine; FOxTROT 4: Oxaliplatin, calcium folinate, infusional fluorouracil, capecitabine, Cetuximab, Encorafenib; FOxTROT 5: Dostarlimab.\n      ", "condition": "\n\tLocally advanced but operable colon cancer\n\tCancer\n\tMalignant neoplasm of colon\n      ", "studyDesign": "Stratified multi-arm multi-site randomized trial platform", "overallEndDate": "2029-08-01T00:00:00.000Z", "clinicalTrialsGovNumber": "NCT06293625", "lastUpdated": "2026-09-03T14:00:50.565041515Z", "eligibility": {"inclusion": "Current inclusion criteria as of 14/08/2024:\nFOxTROT Registration Inclusion Criteria:\n1. Biopsy-confirmed adenocarcinoma of the colon (or upper rectum if too high for radiotherapy); high-grade dysplasia is acceptable with unequivocal radiological evidence of invasive cancer*\n2. Radiological stage T3-4, N0-2, M0\n3. Patient being treated with curative intent\n4. Tumour tissue is available for molecular testing (local or central)\n5. Age ≥18 years at the time of registration\n6. Patient able and willing to provide written informed consent for the study\n* Patients with synchronous colonic tumours are eligible if the most advanced tumour meets the criteria above (please note MMR/MSI testing requirements for randomisation depending upon the location of the most advanced tumour)\n\nFOxTROT 2 Inclusion Criteria:\n1. Patients will be unsuitable for mFOLFOXIRI due to oncologist assessed frailty or comorbidity\n2. Proficient mismatch repair (pMMR)/MSS tumour status for right sided tumours\n3. Colorectal cancer (CRC) specialist-assessed fit to receive 6 weeks of NAC with OxFp (either full or modified dose) and surgery\n4. Adequate full blood count: white blood cell (WBC) >3.0 x 10e9/l; platelets (PLTs) >100 x 10^9/l.\n5. Anaemia (Hb <10.0 g/dl) is not an exclusion, but should be corrected by transfusion prior to\n6. surgery and chemotherapy. If Hb remains low despite transfusions, surgery and chemotherapy can be given at the decision of the surgical and oncology teams.\n7. Adequate renal biochemistry: glomerular filtration rate (GFR) >50 ml/min as assessed by local standards\n8. Adequate hepatobiliary function: bilirubin <1.5 upper limit of normal (ULN) (patients with Gilbert’s syndrome who have raised bilirubin but otherwise normal liver function tests are eligible for the study)\n9. If female and of childbearing potential must agree to avoid pregnancy during and for 6 months after last dose of study treatment\n10. If male with a partner of childbearing potential, must agree to use adequate, medically approved, contraceptive precautions during and for 90 days after the last dose of study treatment\n11. Signed the Informed Consent Document for randomisation\n\nFOxTROT 3 Inclusion Criteria:\n1. Patients need to be fit and suitable for mFOLFOXIRI. There is no fixed age cut-off, but most patients will be under 70 years.\n2. pMMR/MSS tumour status for right sided tumours\n3. Adequate full blood count: WBC >3.0 x10^9/l; Neutrophils ≥1.5 x10^9/l; Plts >100 x10^9/l. Anaemia (Hb < 100 g/l) is not an exclusion, but should be corrected by transfusion prior to surgery and chemotherapy. If Hb remains low despite transfusions, surgery and chemotherapy can be given at the decision of the surgical and oncology teams.\n4. Adequate renal biochemistry: glomerular filtration rate (GFR) >50 ml/min as assessed by local standards\n5. Adequate hepatobiliary function: bilirubin <1.5 upper limit of normal (ULN) (patients with Gilbert’s syndrome who have raised bilirubin but otherwise normal liver function tests are eligible for the study)\n6. If female and of childbearing potential must agree to avoid pregnancy during and for 6 months after last dose of study treatment\n7. If male with a partner of childbearing potential, must agree to use adequate, medically approved, contraceptive precautions during and for 90 days after the last dose of study treatment\n8. Signed the Informed Consent Document for randomisation\n\nFOxTROT 4 inclusion criteria:\n1. pMMR/MSS colon adenocarcinoma (histologically confirmed).\n2. Suitable for surgical resection and peri-operative SACT\n3. No metastatic disease on routine staging investigations.\n4. No prior treatment for bowel cancer\n5. BRAFV600E mutation present in tumour biopsy (tested locally or centrally)\n6. Adequate full blood count: WBC >3.0 x10^9/l; Neutrophils ≥1.5 x10^9/l; Plts ≥100 x10^9/l. Anaemia (Hb < 100 g/l) is not an exclusion but should be corrected by transfusion prior to surgery and SACT. If Hb remains low despite transfusions, surgery and SACT can be given at the decision of the surgical and oncology teams.\n7. Adequate renal biochemistry: GFR >50 ml/min as assessed by local standards\n8. Adequate hepatobiliary function: bilirubin < 1.5 x ULN (Patients with Gilbert’s syndrome who have raised bilirubin, but otherwise normal liver function tests are eligible for the study.) AST /ALT <2.5 x ULN.\n9. If female and of childbearing potential, must agree to avoid pregnancy during and for 6 months after the last dose of study treatment*\n10. If male with a partner of childbearing potential, must agree to use adequate, medically approved, contraceptive precautions during and for 6 months after the last dose of study treatment*\n11. Signed the Informed Consent Document for randomisation\n\nFOxTROT 5 inclusion criteria:\n1. Patients aged 70 years or more and/or with investigator-assessed frailty\n2. dMMR and/or MSI-H tumour status by local or central assessment\n3. Colon cancer specialist assessed fit to receive neoadjuvant dostarlimab and undergo surgery (refer to section 8.1 and Table 1 for guidance on assessing patient suitability for inclusion in FOxTROT 5)\n4. Adequate full blood count: WBC >3.0 x109/l; Platelets >100 x109/l; neutrophils ≥1.5x109/l. Anaemia (Hb <9.0 g/dl) is not an exclusion but should be corrected by transfusion prior to commencement of study treatment. If Hb remains low despite transfusions, surgery and immunotherapy can be given at the discretion of the surgical and oncology teams\n5. Adequate renal biochemistry: GFR ≥30 ml/min/1.73m2 for participants with serum creatinine (Cr) ≥1.5 x ULN OR Cr <1.5 x ULN\n6. Adequate hepatobiliary function: Bilirubin ≤1.5 x ULN (isolated bilirubin >1.5 x ULN is acceptable if bilirubin is fractionated and direct bilirubin <35%) AST/ALT ≤2.5 x ULN\n7. For participants not taking warfarin: INR <1.5 or PT <1.5 x ULN and either PTT or aPTT <1.5 x ULN. Participants taking warfarin may be included on a stable dose with a therapeutic INR <3.5\n8. If female and of childbearing potential, must agree to avoid pregnancy during and for 4 months after last dose of study treatment*\n9. If male with a partner of childbearing potential, must agree to use adequate, medically approved, contraceptive precautions during and for 4 months after the last dose of study treatment*\n10. Signed the Informed Consent Document for participation\n\n_____\n\n\nPrevious inclusion criteria as of 17/10/2023 to 14/08/2024: \nFOxTROT Registration Inclusion Criteria:\n1. Biopsy-confirmed adenocarcinoma of the colon (or upper rectum if too high for radiotherapy); high-grade dysplasia is acceptable with unequivocal radiological evidence of invasive cancer*\n2. Radiological stage T3-4, N0-2, M0\n3. Patient being treated with curative intent\n4. Tumour tissue is available for molecular testing (local or central)\n5. Age ≥18 years at the time of registration\n6. Patient able and willing to provide written informed consent for the study\n* Patients with synchronous tumours are eligible if the most advanced tumour meets the criteria above (please note MMR/MSI testing requirements for randomisation depending upon the location of the most advanced tumour)\n\nFOxTROT 2 Inclusion Criteria:\n1. Patients will be unsuitable for mFOLFOXIRI due to oncologist assessed frailty or comorbidity\n2. Proficient mismatch repair (pMMR)/MSS tumour status for right sided tumours\n3. Colorectal cancer (CRC) specialist-assessed fit to receive 6 weeks of NAC with OxFp (either full or modified dose) and surgery\n4. Adequate full blood count: white blood cell (WBC) >3.0 x 10e9/l; platelets (PLTs) >100 x 10^9/l.\n5. Anaemia (Hb <10.0 g/dl) is not an exclusion, but should be corrected by transfusion prior to\n6. surgery and chemotherapy. If Hb remains low despite transfusions, surgery and chemotherapy can be given at the decision of the surgical and oncology teams.\n7. Adequate renal biochemistry: glomerular filtration rate (GFR) >50 ml/min as assessed by local standards\n8. Adequate hepatobiliary function: bilirubin <1.5 upper limit of normal (ULN) (patients with Gilbert’s syndrome who have raised bilirubin but otherwise normal liver function tests are eligible for the study)\n9. If female and of childbearing potential must agree to avoid pregnancy during and for 6 months after last dose of study treatment\n10. If male with a partner of childbearing potential, must agree to use adequate, medically approved, contraceptive precautions during and for 90 days after the last dose of study treatment\n11. Signed the Informed Consent Document for randomisation\n\nFOxTROT 3 Inclusion Criteria\n1. Patients need to be fit and suitable for mFOLFOXIRI. There is no fixed age cut-off, but most patients will be under 70 years.\n2. pMMR/MSS tumour status for right sided tumours\n3. Adequate full blood count: WBC >3.0 x10^9/l; Neutrophils ≥1.5 x10^9/l; Plts >100 x10^9/l. Anaemia (Hb < 100 g/l) is not an exclusion, but should be corrected by transfusion prior to surgery and chemotherapy. If Hb remains low despite transfusions, surgery and chemotherapy can be given at the decision of the surgical and oncology teams.\n4. Adequate renal biochemistry: glomerular filtration rate (GFR) >50 ml/min as assessed by local standards\n5. Adequate hepatobiliary function: bilirubin <1.5 upper limit of normal (ULN) (patients with Gilbert’s syndrome who have raised bilirubin but otherwise normal liver function tests are eligible for the study)\n6. If female and of childbearing potential must agree to avoid pregnancy during and for 6 months after last dose of study treatment\n7. If male with a partner of childbearing potential, must agree to use adequate, medically approved, contraceptive precautions during and for 90 days after the last dose of study treatment\n8. Signed the Informed Consent Document for randomisation\n\nFOxTROT 4 inclusion criteria\n1. pMMR/MSS colon adenocarcinoma (histologically confirmed).\n2. Suitable for surgical resection and peri-operative SACT\n3. No metastatic disease on routine staging investigations.\n4. No prior treatment for bowel cancer\n5. BRAFV600E mutation present in tumour biopsy (tested locally or centrally)\n6. Adequate full blood count: WBC >3.0 x10^9/l; Neutrophils ≥1.5 x10^9/l; Plts ≥100 x10^9/l. Anaemia (Hb < 100 g/l) is not an exclusion but should be corrected by transfusion prior to surgery and SACT. If Hb remains low despite transfusions, surgery and SACT can be given at the decision of the surgical and oncology teams.\n7. Adequate renal biochemistry: GFR >50 ml/min as assessed by local standards\n8. Adequate hepatobiliary function: bilirubin < 1.5 x ULN (Patients with Gilbert’s syndrome who have raised bilirubin, but otherwise normal liver function tests are eligible for the study.) AST /ALT <2.5 x ULN.\n9. If female and of childbearing potential, must agree to avoid pregnancy during and for 6 months after the last dose of study treatment*\n10. If male with a partner of childbearing potential, must agree to use adequate, medically approved, contraceptive precautions during and for 6 months after the last dose of study treatment*\n11. Signed the Informed Consent Document for randomisation\n\n_____\n\nPrevious inclusion criteria:\nFOxTROT registration inclusion criteria:\n1. Biopsy-confirmed adenocarcinoma of the colon (or upper rectum if too high for radiotherapy); high-grade dysplasia is acceptable with unequivocal radiological evidence of invasive cancer*\n2. Radiological stage T3-4, N0-2, M0 \n3. Patient being treated with curative intent\n4. Tumour tissue is available for mismatch repair (MMR)/microsatellite instability (MSI) testing (local or central)\n5. No clinical or radiological evidence of bowel obstruction\n6. Age ≥18 years at the time of registration\n7. Patient able and willing to provide written informed consent for the study\n* Patients with synchronous tumours are eligible if the most advanced tumour meets the criteria above (please note MMR/MSI testing requirements for randomisation depending upon the location of the most advanced tumour)\n\nFOxTROT 2 inclusion criteria:\n8. Patients will be unsuitable for mFOLFOXIRI due to oncologist assessed frailty or comorbidity\n9. Proficient mismatch repair (pMMR)/MSS tumour status (for rt sided tumours) \n10. Colorectal cancer (CRC) specialist-assessed fit to receive 6 weeks of NAC with OxFp (either full or modified dose) and surgery\n11. Adequate full blood count: white blood cell (WBC) >3.0 x 10e9/l; platelets (PLTs) >100 x 10e9/l. Anaemia (Hb <10.0 g/dl) is not an exclusion, but should be corrected by transfusion prior to surgery and chemotherapy. If Hb remains low despite transfusions, surgery and chemotherapy can be given at the decision of the surgical and oncology teams.\n12. Adequate renal biochemistry: glomerular filtration rate (GFR) >50 ml/min as assessed by local standards\n13. Adequate hepatobiliary function: bilirubin <1.5 upper limit of normal (ULN) (patients with Gilbert’s syndrome who have raised bilirubin but otherwise normal liver function tests are eligible for the study)\n14. If female and of childbearing potential must agree to avoid pregnancy during and for 6 months after study treatment\n15. If male with a partner of childbearing potential, must agree to use adequate, medically approved, contraceptive precautions during and for 90 days after the last dose of study treatment\n16. Signed the Informed Consent Document for randomisation", "exclusion": "Current exclusion criteria as of 14/08/2024:\n\nFOxTROT registration exclusion criteria:\n1. Any patient for whom radiotherapy is advised by the multidisciplinary team (MDT)\n2. Cases with a high index of suspicion of distant metastases or peritoneal nodules (cM1). However, cases with indeterminate abnormalities should be managed and investigated as per standard local MDT procedures and can be considered for trial entry if the MDT opinion is that these are considered most likely to be benign.\n3. Colonic obstruction that has not been defunctioned*\n4. Women who are pregnant or breastfeeding\n* Obstructed patients cannot be included in the FOxTROT trials, unless the obstruction has been relieved. This would usually be by defunctioning. Patients may also be stented, but there is more limited safety data on this and these cases should be individually discussed with the Trial Management Group (TMG).\n\nFOxTROT 2, FOxTROT 3 and FOxTROT 4 Exclusion Criteria:\n1. Serious medical comorbidity, as assessed by the leading clinician (such as uncontrolled angina)\n2. Any other malignant disease within the preceding 5 years with the exception of non-melanomatous skin cancer, carcinoma in situ and early-stage disease with a recurrence risk <10%\n3. Known deficient mismatch repair (dMMR)/microsatellite Instability High (MSI-H) tumour status\n\nFOxTROT 3 Additional Exclusion Criteria:\n1. Known hypersensitivity to oxaliplatin, irinotecan or fluoropyrimidine therapy\n2. Have a peripheral sensitive neuropathy with functional impairment\n3. Have a severe chronic inflammatory bowel condition.\n4. Known complete DPYD deficiency (homozygosity)\n5. Recent or concomitant treatment with brivudine, sorivudine (or their chemically related analogues), St John’s Wort.\n\nFOxTROT 4 Additional Exclusion Criteria:\n1. Impending bowel obstruction\n2. Known hypersensitivity to oxaliplatin, or fluoropyrimidine therapy\n3. Prior treatment with any RAF or EGFR inhibitors\n4. Have a peripheral sensitive neuropathy with functional impairment\n5. Have a severe chronic inflammatory bowel condition.\n6. Known complete DPYD deficiency (homozygosity)\n7. Recent or concomitant treatment with brivudine, sorivudine (or their chemically related analogues), St John’s Wort.\n\nFOxTROT 5 Exclusion Criteria:\n1. Known pMMR or MSS/MSI-L colonic tumour status\n2. Has a known additional malignancy that progressed or required active treatment within the past 2 years. Exceptions include adequately treated superficial skin cancers, superficial bladder cancers, and other in situ cancers\n3. Is immunocompromised in the opinion of the investigator, is receiving any immunosuppressive medication, or has received systemic corticosteroids (>10mg prednisolone daily, or equivalent) within 7 days of first dose of study intervention. Use of inhaled steroids, local injection of steroids, topical steroids, and steroidal eye drops are allowed\n4. Has an active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease-modifying agents, corticosteroids, or immunosuppressive drugs). Replacement therapy (e.g. levothyroxine) is not considered a form of systemic treatment\n5. Experienced any of the following with prior immunotherapy: any Grade 3 or higher immune-related adverse reaction (irAR), anygrade immune-related severe neurologic events (e.g. myasthenic syndrome/myasthenia gravis, encephalitis, Guillain-Barré syndrome, or transverse myelitis), any grade exfoliative dermatitis (Steven-Johnson syndrome, toxic epidermal necrolysis, or DRESS syndrome), any grade myocarditis. Non-clinically significant laboratory abnormalities are not exclusionary\n6. Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to enrolment\n7. Has any history of interstitial lung disease or pneumonitis\n8. Cirrhosis or unstable liver or biliary disease per investigator assessment defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminaemia, oesophageal/gastric varices, or persistent jaundice\n9. Has a history or current evidence of any medical condition, therapy, or laboratory abnormality that might confound the study results, interfere with their participation for the full duration of the study intervention, or indicate it is not in the best interests of the participant to participate, in the opinion of the investigator\n10. Has a history of allogenic stem cell transplantation or organ transplantation\n11. Has a history of congenital long QT syndrome\n12. Has a history or evidence of cardiac abnormalities such as serious, uncontrolled cardiac arrhythmia or clinically significant ECG abnormalities within the 6 months prior to enrolment\n13. Is receiving any other anticancer or experimental therapy\n14. Received a live vaccine within 30 days of planned start of study therapy\n15. Has documented presence of hepatitis B surface antigen (HBsAg) at screening or within 3 months prior to enrolment\n16. Has a positive hepatitis C virus (HCV) antibody test result at screening or within 3 months prior to enrolment. Note: Participants with a positive HCV antibody test result due to prior resolved disease can be enrolled, only if a confirmatory HCV RNA test is obtained\n17. Has a positive HCV RNA test result at screening or within 3 months prior to enrolment. Note: The HCV RNA test is optional and participants with negative HCV antibody test are not required to undergo HCV RNA testing as well\n18. Is considered, in the investigator’s opinion, a poor medical risk due to severe, uncontrolled medical disorder, non-malignant systemic disease, or active infection requiring systemic therapy.\n19. Has known history of human immunodeficiency virus (HIV) infection (unless the specific criteria in the FOxTROT 5 protocol are met)\n20. A known history of severe allergic and/or anaphylactic reactions to chimeric, human or humanized antibodies, fusion proteins, or to dostarlimab or its excipients\n\n______\n\n\nPrevious exclusion criteria as of 17/10/2023 to 14/08/2024: \n\nFOxTROT registration exclusion criteria:\n1. Any patient for whom radiotherapy is advised by the multidisciplinary team (MDT)\n2. Cases with a high index of suspicion of distant metastases or peritoneal nodules (cM1). However, cases with indeterminate abnormalities should be managed and investigated as per standard local MDT procedures and can be considered for trial entry if the MDT opinion is that these are considered most likely to be benign.\n3. Colonic obstruction that has not been defunctioned*\n4. Women who are pregnant or breastfeeding\n* Obstructed patients cannot be included in the FOxTROT trials, unless the obstruction has been relieved. This would usually be by defunctioning. Patients may also be stented, but there is more limited safety data on this and these cases should be individually discussed with the Trial Management Group (TMG).\n\nFOxTROT 2, FOxTROT 3 and FOxTROT 4 Exclusion Criteria:\n1. Serious medical comorbidity, as assessed by the leading clinician (such as uncontrolled angina)\n2. Any other malignant disease within the preceding 5 years with the exception of non-melanomatous skin cancer, carcinoma in situ and early-stage disease with a recurrence risk <10%\n3. Known deficient mismatch repair (dMMR)/microsatellite Instability High (MSI-H) tumour status\n\nFOxTROT 3 Additional Exclusion Criteria:\n1. Known hypersensitivity to oxaliplatin, irinotecan or fluoropyrimidine therapy\n2. Have a peripheral sensitive neuropathy with functional impairment\n3. Have a severe chronic inflammatory bowel condition.\n4. Known complete DPYD deficiency (homozygosity)\n5. Recent or concomitant treatment with brivudine, sorivudine (or their chemically related analogues), St John’s Wort.\n\nFOxTROT 4 Additional Exclusion Criteria:\n1. Impending bowel obstruction\n2. Known hypersensitivity to oxaliplatin, or fluoropyrimidine therapy\n3. Prior treatment with any RAF or EGFR inhibitors\n4. Have a peripheral sensitive neuropathy with functional impairment\n5. Have a severe chronic inflammatory bowel condition.\n6. Known complete DPYD deficiency (homozygosity)\n7. Recent or concomitant treatment with brivudine, sorivudine (or their chemically related analogues), St John’s Wort.\n\n_____\n\nPrevious exclusion criteria:\n\nFOxTROT randomisation exclusion criteria:\n1. Any patient for whom radiotherapy is advised by the multidisciplinary team (MDT)\n2. Strong evidence of distant metastases or peritoneal nodules (cM1), however patients with lung lesions of uncertain significance (<5 mm) are eligible\n3. Peritonitis (secondary to perforated tumour)\n4. Colonic obstruction that has not been defunctioned*\n* Obstructed patients cannot be included in the FOxTROT trials, unless the obstruction has been relieved. This would usually be by defunctioning. Patients may also be stented, but there is more limited safety data on this and these cases should be individually discussed with the Trial Management Group (TMG).\n\nFOxTROT 2 exclusion criteria:\n5. Serious medical comorbidity, as assessed by the leading clinician (such as uncontrolled angina)\n6. Any other malignant disease within the preceding 5 years with the exception of non-melanomatous skin cancer, carcinoma in situ and early-stage disease with a recurrence risk <10%\n7. Known deficient mismatch repair (dMMR)/microsatellite Instability High (MSI-H) tumour status", "ageRange": "Mixed", "gender": "All", "participantType": "Patient"}, "recruitment": {"recruitmentStart": "2022-02-07T00:00:00.000Z", "recruitmentEnd": "2027-04-01T00:00:00.000Z", "recruitmentStatusOverride": "", "recruitmentStartStatusOverride": "", "targetEnrolment": "1703", "totalFinalEnrolment": "0"}, "countries": ["United Kingdom", "England", "Scotland", "Wales", "Australia", "France", "India", "Netherlands", "Sweden"], "locations": [{"name": "Airedale General Hospital", "city": "Keighley", "state": "", "country": "England", "zip": "BD20 6TD"}, {"name": "St Bartholomew's Hospital", "city": "London", "state": "", "country": "England", "zip": "EC1A 7BE"}, {"name": "Ysbyty Gwynedd", "city": "Bangor", "state": "", "country": "Wales", "zip": "LL57 2PW"}, {"name": "Bradford Royal Infirmary", "city": "Bradford", "state": "", "country": "England", "zip": "BD9 6RJ"}, {"name": "Calderdale Rotal 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"state": "", "country": "England", "zip": "TN37 7RD"}, {"name": "Bensham Hospital", "city": "Gateshead", "state": "", "country": "England", "zip": "NE8 4YL"}, {"name": "Great Western Hospital", "city": "Swindon", "state": "", "country": "England", "zip": "SN3 6BB"}, {"name": "Basingstoke and North Hampshire Hospital", "city": "Basingstoke", "state": "", "country": "England", "zip": "RG24 9NA"}, {"name": "Charing Cross Hospital and St Mary's", "city": "London", "state": "", "country": "England", "zip": "W6 8RF"}, {"name": "Kettering General Hospital", "city": "Kettering", "state": "", "country": "England", "zip": "NN16 8UZ"}, {"name": "St James's University Hospital", "city": "Leeds", "state": "", "country": "England", "zip": "LS9 7TF"}, {"name": "Queen Elizabeth Hospital & Lewisham Hospital", "city": "London", "state": "", "country": "England", "zip": "SE18 4QH"}, {"name": "Royal Liverpool University Hospital", "city": "Liverpool", "state": "", "country": "England", "zip": "L7 8XP"}, {"name": "Manchester Royal Infirmary", "city": "Manchester", "state": "", "country": "England", "zip": "M13 9WL"}, {"name": "Crosshouse Hospital", "city": "Kilmarnock", "state": "", "country": "Scotland", "zip": "KA2 0BE"}, {"name": "Queen Margaret Hospital and Victoria Hospital", "city": "Dunfermline", "state": "", "country": "Scotland", "zip": "KY12 0SU"}, {"name": "Forth Valley Royal Hospital", "city": "Larbert", "state": "", "country": "Scotland", "zip": "FK5 4WR"}, {"name": "Beatson West of Scotland Cancer Centre", "city": "Glasgow", "state": "", "country": "Scotland", "zip": "G12 0YN"}, {"name": "Royal Edinburgh Hospital", "city": "Edinburgh", "state": "", "country": "Scotland", "zip": "EH10 5HF"}, {"name": "Norfolk & Norwich University Hospital", "city": "Norwich", "state": "", "country": "England", "zip": "NR4 7UY"}, {"name": "Northampton General Hospital", "city": "Northampton", "state": "", "country": "England", "zip": "NN1 5BD"}, {"name": "Hexham General Hospital", "city": "Hexham", "state": "", "country": "England", "zip": "NE46 1QJ"}, {"name": "Queen Alexandra Hospital", "city": "Portsmouth", "state": "", "country": "England", "zip": "PO6 3LY"}, {"name": "Royal Cornwall Hospital", "city": "Truro", "state": "", "country": "England", "zip": "TR1 3LJ"}, {"name": "Royal Devon and Exeter Hospital", "city": "Exeter", "state": "", "country": "England", "zip": "EX2 5DW"}, {"name": "Royal Free Hospital", "city": "London", "state": "", "country": "England", "zip": "NW3 2QG"}, {"name": "Royal United Hospital", "city": "Bath", "state": "", "country": "England", "zip": "BA1 3NG"}, {"name": "Weston Park Cancer Centre", "city": "Sheffield", "state": "", "country": "England", "zip": "S10 2SJ"}, {"name": "St George's Hospital", "city": "London", "state": "", "country": "England", "zip": "SW17 0QT"}, {"name": "Musgrove Park Hospital", "city": "Taunton", "state": "", "country": "England", "zip": "TA1 5DA"}, {"name": "The Christie", "city": "Manchester", "state": "", "country": "England", "zip": "M20 4BX"}, {"name": "Clatterbridge Cancer Centre Liverpool and Clatterbridge Cancer Centre Wirral", "city": "Wirral", "state": "", "country": "England", "zip": "CH63 4JY"}, {"name": "The Royal Marsden Hospital (Chelsea and Sutton)", "city": "London", "state": "", "country": "England", "zip": "SW3 6JJ"}, {"name": "Royal Surrey County Hospital", "city": "Guildford", "state": "", "country": "England", "zip": "GU2 7XX"}, {"name": "Harrogate District Hospital", "city": "Harrogate", "state": "", "country": "England", "zip": "HG2 7SX"}, {"name": "Lincoln County Hospital", "city": "Lincoln", "state": "", "country": "England", "zip": "LN2 5QY"}, {"name": "UCL Cancer Institute", "city": "London", "state": "", "country": "England", "zip": "WC1E 6DD"}, {"name": "Bristol Cancer Centre", "city": "Bristol", "state": "", "country": "England", "zip": "BS2 8ED"}, {"name": "University Hospital Coventry", "city": "Coventry", "state": "", "country": "England", "zip": "CV2 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"England", "zip": "WN1 2NN"}, {"name": "York Teaching Hospital", "city": "York", "state": "", "country": "England", "zip": "YO31 8HE"}, {"name": "Dorset County Hospital", "city": "Dorchester", "state": "", "country": "England", "zip": "DT1 2JY"}, {"name": "Colchester Hospital", "city": "Colchester", "state": "", "country": "England", "zip": "CO4 5JL"}, {"name": "George Eliot Hospital", "city": "Nuneaton", "state": "", "country": "England", "zip": "CV10 7DJ"}, {"name": "University Hospital Monklands", "city": "Airdrie", "state": "", "country": "Scotland", "zip": "ML6 0JS"}, {"name": "University Hospital of North Tees", "city": "Stockton-on-Tees", "state": "", "country": "England", "zip": "TS19 8PE"}, {"name": "The James Cook University Hospital", "city": "Middlesbrough", "state": "", "country": "England", "zip": "TS4 3BW"}, {"name": "Warwick Hospital", "city": "Warwick", "state": "", "country": "England", "zip": "CV34 5BW"}, {"name": "East Yorkshire Hospitals NHS Trust (head Office)", "city": "Cottingham", "state": "", "country": "England", "zip": "HU16 5JQ"}, {"name": "Mid Cheshire Hospitals NHS Foundation Trust", "city": "Crewe", "state": "", "country": "England", "zip": "CW1 4QJ"}, {"name": "Milton Keynes University Hospital", "city": "Milton Keynes", "state": "", "country": "England", "zip": "MK6 5LD"}, {"name": "University Hospital Crosshouse", "city": "Kilmarnock", "state": "", "country": "Scotland", "zip": "KA2 0BE"}, {"name": "Queen Margaret Hospital", "city": "Dunfermline", "state": "", "country": "Scotland", "zip": "KY12 0SU"}, {"name": "Victoria Hospital", "city": "Kirkcaldy", "state": "", "country": "Scotland", "zip": "KY2 5AH"}, {"name": "Ninewells Hospital", "city": "Dundee", "state": "", "country": "Scotland", "zip": "DD1 9SY"}, {"name": "Churchill Hospital", "city": "Oxford", "state": "", "country": "England", "zip": "OX3 7LE"}, {"name": "Singleton Hospital", "city": "Swansea", "state": "", "country": "Wales", "zip": "SA2 8QA"}, {"name": "Queen Elizabeth Hospital", "city": "Birmingham", "state": "", "country": "England", "zip": "B15 2GW"}, {"name": "Yeovil Hospital Bcsc", "city": "Yeovil", "state": "", "country": "England", "zip": "BA21 4AT"}, {"name": "Christian Medical College and Hospital (Local Sponsor for FOxTROT 2 only)", "city": "Ludhiana", "state": "", "country": "India", "zip": "141008"}, {"name": "CHU DIJON (Local Sponsor for FOxTROT 2 only)", "city": "Dijon", "state": "", "country": "France", "zip": "21000"}], "sponsors": [{"organisation": "University of Leeds", "sponsorType": "University/education", "rorId": "https://ror.org/024mrxd33"}], "funders": [{"name": "Yorkshire Cancer Research", "fundRef": "http://dx.doi.org/10.13039/100011703"}, {"name": "Merck"}, {"name": "Pierre Fabre"}, {"name": "GSK"}]}, "studySha256": "e6970c43a94acbbd01eb02c91e42ae1c305b8f4ce45df51ec7af6fd29b66b8fa"}