Nordic.
Methods | Multicentre randomised controlled trial. Generation of allocation schedule truly random (personal communication with investigator). |
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Participants | 183 patients with noncurable, asymptomatic colorectal cancer who have received no previous cytostatic therapy. Age <= 75 years. Normal kidney function, no icterus, no evidence of ascites or pleural effusion | |
Interventions | Methotrexate (250mg/m2 infusion over 2 hours) + 5‐Fluorouracil (500mg/m2 iv bolus x 2) + Leucovorin rescue (15mg IM followed by seven oral doses of 15mg). Treatment repeated every 14 days for 8 courses, every 3 weeks for 2 courses and every 4 weeks for 2 courses. Therapy continued for 12 courses (6 months) unless tumour progression or severe adverse effects vs Primary expectancy. Chemotherapy was allowed when patients became symptomatic. | |
Outcomes | Survival, Symptom‐free survival, Progression, Tumour response, Toxicity Quality of life was studied in a subset at one centre | |
Notes | 51/90 patients in supportive care group received chemotherapy when became symptomatic. Analysis by intention to treat. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Allocation concealment? | Low risk | A ‐ Adequate |