{"registry": "ISRCTN", "registryId": "ISRCTN10639376", "source": "https://www.isrctn.com/ISRCTN10639376", "apiSource": "https://www.isrctn.com/api/trial/ISRCTN10639376/format/default", "fetchedAt": "2026-10-07T17:00:16.368671Z", "license": "CC BY 4.0", "licenseSource": "https://www.isrctn.com/page/faqs#licence-to-post", "study": {"title": "A trial looking at whether stereotactic radiotherapy together with chemotherapy is a useful treatment for people with locally advanced bile duct cancer (ABC-07)", "scientificTitle": "Addition of stereotactic body radiotherapy to systemic chemotherapy in locally advanced biliary tract cancers", "acronym": "ABC-07", "hypothesis": "1. The overall aim of the feasibility component of the trial is to determine if it is feasible to deliver SBRT in a multi-centre trial setting in a rare disease\n2. The overall aim of the phase II trial is to evaluate the efficacy of 8 cycles of CisGem chemotherapy compared to 6 of cycles of CisGem chemotherapy followed by SBRT", "primaryOutcome": "Current primary outcome as of 17/08/2026:\nThe efficacy of 6 cycles of CisGem followed by SBRT versus 8 cycles of CisGem, measured using progression-free survival (PFS), assessed from randomisation to disease progression (RECIST v1.1 on CT/MRI) or death from any cause.\n\nPrevious primary outcome:\nAverage monthly rate of recruitment is determined over the 18-month trial period", "secondaryOutcome": "Added 17/08/2026:\n1. Progression-free survival (PFS) measured using CT and/or MRI imaging assessments (RECIST v1.1) and death from any cause, at 9 months from randomisation\n2. The frequency and severity of toxicities measured using CTCAE v4.03 at registration, all treatment visits, completion of treatment, and all follow up visits.\n3. Best overall response will be assessed according to RECIST v1.1. Confirmation of a complete or partial response is not required. Stable disease will be considered the best response only if a second assessment has been carried out which confirms SD at least 4 weeks after registration. The proportion of patients whose best overall response is complete or partial will be presented.\n4. The duration of overall response is measured from the time of best overall response until the date of objective disease progression on CT and/or MRI.\n5. Sites of treatment failure measured using CT and/or MRI assessment of local progression, regional progression and distant metastases according to protocol-defined radiological criteria, at all scheduled follow-up visits from treatment completion.\n6. The potential for CisGem + SBRT to downstage inoperable disease to operable disease, measured using the proportion of patients achieving downstaging permitting surgical resection, at treatment completion.\n7. Overall survival measured from the date of randomisation to the date of death from any cause. The effect of treatment on overall survival will be summarised using Kaplan-Meier curves. Cox regression will be used to assess the effect of treatment on overall survival, and hazard ratios, 95% confidence interval and p-values will be reported.\n8. Quality of life (QoL) measured using the EQ5D and EORTC QLQ- BIL21 questionnaires. Analysis of covariance will be used to assess treatment differences in the quality of life scores at completion of treatment and at 3 months follow-up, adjusting for baseline scores (registration and end of cycle 4).", "intervention": "\n\tCurrent interventions as of 19/07/2017:\nAll patients will be registered to receive 6 cycles of chemotherapy consisting of cisplatin 25 mg/m2 plus gemcitabine 1000 mg/m2 on days 1 and 8 of a 21-day cycle. Treatment takes about 2 hours each time. \nPatients will then be randomised to one of two groups.\n\nInvestigational arm: Participants receive 5 or 15 fractions of SBRT over 5-21 days approximately 6 weeks after the start of cycle 6. (Number of fractions and duration of treatment depends on size of tumour on end of cycle 4 imaging). \n\nStandard arm: Participants receive 2 further cycles of CisGem (8 cycles in total) \n\nAll patients will be followed up every 3 months for up to 2 years from date of registration.\n\nPrevious interventions:\nAll patients will be registered to receive 6 cycles of chemotherapy consisting of cisplatin 25 mg/m2 plus gemcitabine 1000 mg/m2 on days 1 and 8 of a 21-day cycle. Treatment takes about 2 hours each time. \nPatients will then be randomised to one of two groups.\n\nInvestigational arm: Participants receive 5 fractions of SBRT over 5-15 days approximately 6 weeks after the start of cycle 6.\n\nStandard arm: Participants 2 further cycles of CisGem (8 cycles in total) \n\nAll patients will be followed up every 3 months for up to 2 years from date of registration.\n\tOther\n\t\n\t\n      ", "condition": "\n\tBiliary tract cancer\n\tCancer\n\tMalignant neoplasm of other and unspecified parts of biliary tract\n      ", "studyDesign": "Randomized; Interventional; Design type: Treatment", "overallEndDate": "2026-08-12T00:00:00.000Z", "clinicalTrialsGovNumber": "", "lastUpdated": "2026-08-17T10:22:41.644259302Z", "eligibility": {"inclusion": "Current inclusion criteria as of 19/07/2017:\n1. A histopathological/cytological diagnosis of locally advanced, non­-resectable biliary tract carcinoma (intra­ or extrahepatic), or ampullary carcinoma\n2. Not suitable for radical surgery, or medically unfit for surgery as decided by a hepatobiliary MDT\n3. Tumour visible on cross­sectional imaging\n4. Measurable disease (according to RECIST criteria v1.1) (If disease is not measurable using RECIST v1.1, due to location in the vicinity of the hilum, the tumour must be visible for targeting with radiation using other multimodality imaging such as ERCP, MRCP)\n5. Tumour (and nodes if involved) must be ≤12 cm in the longest dimension. For patients with non-measurable disease, sites should use the CT reconstructions (coronal or sagittal views) to measure tumour size.\n6. Adequate biliary drainage\n7. WHO performance status (PS) 0 or 1\n8. Adequate haematological function:\n8.1. Haemoglobin ≥ 100 g/L (the use of transfusion to achieve desired Hb is acceptable)\n8.2. White blood cell count (WBC) ≥ 3.0 x 109/L\n8.3. Absolute neutrophil count (ANC) ≥ 1.5 x 109/L\n8.4. Platelet count ≥ 100 x 109/L \n9. Adequate liver function:\n9.1. Total bilirubin ≤ 1.5 x ULN (except for patients with known documented cases of Gilbert’s syndrome)\n9.2. ALT and/or AST ≤ 2.5 x ULN\n9.3. ALP ≤ 5 x ULN\n9.4. Albumin >25g/L\n10. Adequate renal function:\n10.1. Serum urea < 1.5 x ULN\n10.2. Serum creatinine < 1.5 x ULN\n10.3. GFR ≥ 45 mL/min using a validated creatinine clearance calculation (e.g. Cockroft­Gault or Wright formula). If the calculated creatinine clearance is less than 45 mL/min, GFR should be assessed using an isotopic clearance method to confirm GFR ≥ 45 mL/min\n11. Life expectancy of more than 12 weeks\n12. Aged 16 years or over\n13. Patients may have had prior chemotherapy as long as patient meets all other inclusion/exclusion criteria\n14. Patient must have given written informed consent\n\nPreviously inclusion criteria:\n1. A histopathological/cytological diagnosis of locally advanced, non­-resectable biliary tract carcinoma (intra­ or extrahepatic), or ampullary carcinoma\n2. Not suitable for radical surgery, or medically unfit for surgery as decided by a hepatobiliary MDT\n3. Tumour visible on cross­sectional imaging\n4. Measurable disease (according to RECIST criteria v1.1)\n5. Tumour must be ≤ 6 cm in the longest dimension\n6. Adequate biliary drainage\n7. WHO performance status (PS) 0 or 1\n8. Adequate haematological function:\n8.1. Haemoglobin ≥ 100 g/L (the use of transfusion to achieve desired Hb is acceptable)\n8.2. White blood cell count (WBC) ≥ 3.0 x 109/L\n8.3. Absolute neutrophil count (ANC) ≥ 1.5 x 109/L\n8.4. Platelet count ≥ 100 x 109/L \n9. Adequate liver function:\n9.1. Total bilirubin ≤ 1.5 x ULN (except for patients with known documented cases of Gilbert’s syndrome)\n9.2. ALT and/or AST ≤ 2.5 x ULN\n9.3. ALP ≤ 5 x ULN\n9.4. Albumin >25g/L\n10. Adequate renal function:\n10.1. Serum urea < 1.5 x ULN\n10.2. Serum creatinine < 1.5 x ULN\n10.3. GFR ≥ 45 mL/min using a validated creatinine clearance calculation (e.g. Cockroft­Gault or Wright formula). If the calculated creatinine clearance is less than 45 mL/min, GFR should be assessed using an isotopic clearance method to confirm GFR ≥ 45 mL/min\n11. Life expectancy of more than 12 weeks\n12. Aged 16 years or over\n13. Patients may have had prior chemotherapy as long as patient meets all other inclusion/exclusion criteria\n14. Patient must have given written informed consent", "exclusion": "Current exclusion criteria as of 19/07/2017:\n1. Metastatic disease\n2. Direct tumour extension in the duodenum, stomach, small bowel or large bowel.\n3. Previous abdominal radiotherapy or previous selective internal radiotherapy such as hepatic arterial Yttrium therapy\n4. Previous hypersensitivity to platinum salts\n5. Any evidence of severe or uncontrolled systemic diseases which, in the view of the investigator, makes it undesirable for the patient to participate in the trial (including diabetes with established sensory peripheral neuropathy, unstable or uncompensated respiratory, cardiac, hepatic or renal disease)\n6. History of prior malignancy that could interfere with the response evaluation or survival. (Exceptions include: in­situ carcinoma of the cervix treated by cone­biopsy/resection, non­metastatic basal and/or squamous cell carcinomas of the skin, or any early stage malignancy radically treated in the last two years, early prostate cancer under surveillance.\n7. Other concomitant anti­cancer therapy (except steroids)\n8. Any psychiatric or other disorder likely to impact on informed consent.\n9. Women who are pregnant or lactating\n10. Whilst not specifically excluded, patients with significant hearing impairment must be made aware of potential ototoxicity and may choose not to be included. If included, it is recommended that audiograms be carried out at baseline and prior cycle 2 of CisGem.\n\nPrevious exclusion criteria:\n1. Metastatic disease\n2. Direct tumour extension in the duodenum, stomach, small bowel or large bowel.\n3. Previous abdominal radiotherapy or previous selective internal radiotherapy such as hepatic arterial Yttrium therapy\n4. Previous hypersensitivity to platinum salts\n5. Any evidence of severe or uncontrolled systemic diseases which, in the view of the investigator, makes it undesirable for the patient to participate in the trial (including diabetes with established sensory peripheral neuropathy, unstable or uncompensated respiratory, cardiac, hepatic or renal disease)\n6. History of prior malignancy that could interfere with the response evaluation (exceptions include in­situ carcinoma of the cervix treated by cone­biopsy/resection, non­metastatic basal and/or squamous cell carcinomas of the skin, or any early stage (stage I) malignancy adequately resected for cure greater than 5 years previously)\n7. Other concomitant anti­cancer therapy (except steroids)\n8. Any psychiatric or other disorder likely to impact on informed consent.\n9. Women who are pregnant or lactating\n10. Whilst not specifically excluded, patients with significant hearing impairment must be made aware of potential ototoxicity and may choose not to be included. If included, it is recommended that audiograms be carried out at baseline and prior cycle 2 of CisGem.", "ageRange": "Mixed", "gender": "All", "participantType": "Patient"}, "recruitment": {"recruitmentStart": "2015-11-01T00:00:00.000Z", "recruitmentEnd": "2022-08-03T00:00:00.000Z", "recruitmentStatusOverride": "", "recruitmentStartStatusOverride": "", "targetEnrolment": "83", "totalFinalEnrolment": "83"}, "countries": ["United Kingdom", "England", "Scotland", "Wales"], "locations": [{"name": "Churchill Hospital", "city": "Oxford", "state": "", "country": "England", "zip": "OX3 7LE"}, {"name": "University College Hospital", "city": "London", "state": "", "country": "England", "zip": "NW1 2BU"}, {"name": "The Royal Marsden Hospital (Surrey)", "city": "Sutton", "state": "", "country": "England", "zip": "SM2 5PT"}, {"name": "The Royal Marsden Hospital", "city": "London", "state": "", "country": "England", "zip": "SW3 6JJ"}, {"name": "Mount Vernon Cancer Centre", "city": "Northwood", "state": "", "country": "England", "zip": "HA6 2RN"}, {"name": "Lister Hospital", "city": "London", "state": "", "country": "England", "zip": "SG1 4AB"}, {"name": "Royal Free Hospital", "city": "London", "state": "", "country": "England", "zip": "NW3 2QG"}, {"name": "Velindre Cancer Centre", "city": "Cardiff", "state": "", "country": "Wales", "zip": "CF14 2TL"}, {"name": "St Bart’s Hospital", "city": "London", "state": "", "country": "England", "zip": "EC1A 7BE"}, {"name": "Hammersmith Hospital", "city": "London", "state": "", "country": "England", "zip": "W12 0HS"}, {"name": "Southampton General Hospital", "city": "Southampton", "state": "", "country": "England", "zip": "SO16 6YD"}, {"name": "Addenbrooke’s Hospital", "city": "Cambridge", "state": "", "country": "England", "zip": "CB2 0QQ"}, {"name": "Queen Elizabeth Hospital", "city": "Birmingham", "state": "", "country": "England", "zip": "B15 2TH"}, {"name": "Christie Manchester", "city": "Manchester", "state": "", "country": "England", "zip": "M20 4BX"}, {"name": "Nottingham City Hospital", "city": "Nottingham", "state": "", "country": "England", "zip": "NG5 1PB"}, {"name": "Beatson West of Scotland Cancer Centre", "city": "Glasgow", "state": "", "country": "Scotland", "zip": "G12 0YN"}, {"name": "Bristol Haematology & Oncology Centre", "city": "Bristol", "state": "", "country": "England", "zip": "BS2 8ED"}, {"name": "Guy's and St Thomas' Hospitals", "city": "London", "state": "", "country": "England", "zip": "SE1 9RT"}, {"name": "Leeds Teaching Hospitals NHS Trust", "city": "Leeds", "state": "", "country": "England", "zip": "LS9 7TF"}, {"name": "Weston Park Hospital", "city": "Sheffield", "state": "", "country": "England", "zip": "S10 2SJ"}], "sponsors": [{"organisation": "University College London", "sponsorType": "University/education", "rorId": "https://ror.org/02jx3x895"}], "funders": [{"name": "Cancer Research UK", "fundRef": "http://dx.doi.org/10.13039/501100000289"}]}, "studySha256": "d845644b7255977db008b1dff83f0b8e7bf57d5826c684903a193ae856cff432"}