Glimelius.
Methods | Single centre randomised controlled trial. Generation of allocation schedule truly random. |
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Participants | 21 patients with surgically non‐curable colorectal cancer. Age <= 75 years. Excluded if Karnofsky performance status <50, previous chemotherapy, other primary tumours or exceeded specified levels of serum creatinine and bilirubin. | |
Interventions | Primary chemotherapy : 5‐Fluorouracil (500 mg/m2 ) and leucovorin (60 mg/m2 ) on days 1&2, every 2nd week. Treatment continued until tumour progression, either objectively or subjectively, as long as toxicity was low. Treatment could be discontinued after 4 months if stable disease and it was believed that that this would provide better palliation. If a patient had no tumour‐related symptoms, the planned number of treatments was 10 courses. vs Best supportive care including psychosocial support and attempts to relieve any symptoms. Chemotherapy was allowed in this group if the supportive measure did not achieve palliation, or if the patient requested chemotherapy. | |
Outcomes | Survival, Tumour response, Toxicity, Quality of Life, Costs | |
Notes | These patients are taken from a randomised controlled trial of 61 patients with advanced gastrointestinal cancer (stratified according to primary disease). In the entire group, 15/28 patients who were randomised to supportive care ultimately received chemotherapy. Analysis appears to be intention to treat (not explicitly stated) | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Allocation concealment? | Low risk | A ‐ Adequate |