{"registry": "ISRCTN", "registryId": "ISRCTN13826061", "source": "https://www.isrctn.com/ISRCTN13826061", "apiSource": "https://www.isrctn.com/api/trial/ISRCTN13826061/format/default", "fetchedAt": "2026-10-07T17:08:33.900638Z", "license": "CC BY 4.0", "licenseSource": "https://www.isrctn.com/page/faqs#licence-to-post", "study": {"title": "A phase III multi-centre randomised controlled trial to assess whether optimal supportive care alone (including dexamethasone) is as effective as optimal supportive care (including dexamethasone) plus whole brain radiotherapy in the treatment of patients with inoperable brain metastases from non-small cell lung cancer", "scientificTitle": "A phase III multi-centre randomised controlled trial to assess whether optimal supportive care alone (including dexamethasone) is as effective as optimal supportive care (including dexamethasone) plus whole brain radiotherapy in the treatment of patients with inoperable brain metastases from non-small cell lung cancer", "acronym": "QUARTZ (Quality of Life After Radiotherapy and Steroids)", "hypothesis": "That optimal supportive care (including dexamethasone) alone is as effective as optimal supportive care (including dexamethasone) plus whole brain radiotherapy, in terms of patient-assessed quality-adjusted life-years in patients with non-small cell lung cancer (NSCLC) and inoperable brain metastases.", "primaryOutcome": "Quality-adjusted life-years. Follow-up is weekly until 12 weeks, then 4 weekly, until death.", "secondaryOutcome": "1. Overall survival\n2. Karnofsky Performance Status\n3. Patient symptoms\nFollow-up is weekly until 12 weeks, then 4 weekly, until death.", "intervention": "\n\tOptimal supportive care (OSC, including dexamethasone) alone versus OSC and whole brain radiotherapy (WBRT).\n\tDrug\n\tPhase III\n\tDexamethasone\n      ", "condition": "\n\tNon-small cell lung cancer with inoperable brain metastases\n\tCancer\n\tLung cancer\n      ", "studyDesign": "Phase III multi-centre randomised controlled trial", "overallEndDate": "2015-05-31T00:00:00.000Z", "clinicalTrialsGovNumber": "NCT00403065", "lastUpdated": "2022-03-24T14:01:01.979Z", "eligibility": {"inclusion": "1. Histologically or cytologically proven primary NSCLC\n2. Computed tomography (CT)/magnetic resonance imaging (MRI) confirming brain metastases\n3. Inoperable brain metastases as assessed by a lung cancer Multi-Disciplinary Team (MDT) or patients for whom surgery is deemed inappropriate\n4. Clinician and patient uncertain of the role of whole brain radiotherapy (WBRT)\n5. Patient able and willing to respond to questions in a weekly telephone assessment\n6. Patient able and willing to give informed consent\n7. Aged over 18 years\n8. Baseline patient assessment form completed", "exclusion": "Current exclusion criteria as of 14/01/2014:\n1. Clinician and/or patient certain that WBRT will be of benefit\n2. Clinician and/or patient certain that WBRT will not be of benefit\n3. Previous or current illness, which has not been brought under control and/or is likely to interfere with protocol treatment or comparisons\n4. Chemotherapy (last cycle) within 3 weeks prior to randomisation\n5. Previous radiotherapy to the brain\n6. Surgery for brain metastases within one month prior to randomisation\n\nPrevious exclusion criteria:\n1. Clinician and/or patient certain that WBRT will be of benefit\n2. Clinician and/or patient certain that WBRT will not be of benefit\n3. Previous or current illness, which has not been brought under control and/or is likely to interfere with protocol treatment or comparisons\n4. Estimated glomerular filtration rate (EGFR) inhibitors within one week prior to randomisation\n5. Chemotherapy (last cycle) within one month prior to randomisation\n6. Previous radiotherapy to the brain\n7. Surgery for brain metastases within one month prior to randomisation", "ageRange": "Adult", "gender": "All", "participantType": "Patient"}, "recruitment": {"recruitmentStart": "2007-03-02T00:00:00.000Z", "recruitmentEnd": "2014-08-31T00:00:00.000Z", "recruitmentStatusOverride": "", "recruitmentStartStatusOverride": "", "targetEnrolment": "534", "totalFinalEnrolment": ""}, "countries": ["United Kingdom", "England", "Australia"], "locations": [{"name": "Newcastle General Hospital", "city": "Newcastle upon Tyne", "state": "", "country": "United Kingdom", "zip": "NE4 6BE"}], "sponsors": [{"organisation": "Medical Research Council (MRC) (UK)", "sponsorType": "Research organisation", "rorId": "https://ror.org/03x94j517"}], "funders": [{"name": "Cancer Research UK (CRUK) (UK) (ref: C17956/A6414)", "fundRef": "http://dx.doi.org/10.13039/501100000289"}]}, "studySha256": "79071675ea6c99851f75d6b18ded0a2593762c3f055d81855f958e87bb245239"}