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. |
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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 Analysis not by intention to treat as 4 patients were withdrawn after randomisation.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 |