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. 2000 Jan 24;2000(1):CD001545. doi: 10.1002/14651858.CD001545

Nordic.

Methods Multicentre randomised controlled trial.
Generation of allocation schedule truly random (personal communication with investigator).
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