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

Scheithauer.

Methods Single centre randomised controlled trial.
Generation of allocation schedule by computer generated random number list (adequate).
Ratio of chemotherapy to supportive care 2:1.
Participants 40 previously untreated patients with inoperable, locally recurrent or metastatic colorectal cancer. Age < 75 yrs, life expectancy > 2 months, ECOG performance status <=3. Specified levels of haematological, renal and hepatic function for inclusion.
Interventions Leucovorin bolus i.v. (200mg/m2/day) plus 5‐Fluorouracil bolus i.v. (550mg/m2/day) plus Cisplatin infusion (20mg/m2/day). All drugs given on 4 consecutive days at 4 week intervals. Continued for total of 6 months or until evidence of disease progression 
 vs 
 Supportive care : analgesia, nutritional support, blood transfusion, and psychosocial support as required.
Outcomes Survival, Quality of life, Toxicity
Notes 2/12 evaluable patients in supportive care group received chemotherapy. 
 Analysis not by intention to treat as 4 patients were withdrawn after randomisation.
Risk of bias
Bias Authors' judgement Support for judgement
Allocation concealment? Low risk A ‐ Adequate