| Methods |
Design: 2‐arm parallel trial with a no‐treatment control group
No. of centres: unclear
Recruitment and setting: Medical Institute Oncology Service and Guernes Center, Buenos Aires, Argentina
Recruitment period: 12/83‐12/85
Observation period: up to 42 months
Ethical approval: unclear |
| Participants |
No. of patients: 32 randomised, 32 evaluated
Condition: colorectal cancer, Dukes B2, C1, C2 after surgery; colon cancer (29), rectal cancer (4)
Demographics: women: 15, men: 17; mean age: women: 58.8, men: 61.8 years
Informed consent: unclear |
| Interventions |
Interventional treatment: thymostimulin; dose/schedule: 25 mg/m² i.m. every chemotherapy cycle (d9‐13,17,19, 24, 26)
Control treatment: no treatment
Basic treatment : 5‐fluoruracil 600 mg/m² i.v. (d1,d8), lomustine 60 mg/m² p.o. (d1); every 3 weeks; for 6 months |
| Outcomes |
Outcome measures: survival, toxicity (AEs of chemo‐/radiotherapy), other |
| Notes |
Participants: no reporting of distribution of risk factors between groups
Outcomes: side effects of chemotherapy were not scored using standardized criteria |
