| Methods |
Design: 2‐arm parallel trial with a no‐treatment control group
No. of centres: 1 or 2
Recruitment and setting: Hospital C. Forlanini and Clinic of Respiratory Diseases, University of Rome, Italy
Recruitment period: unclear
Observation period: 6 months
Ethical approval: unclear |
| Participants |
No. of patients: 46 randomised, 40 evaluated
Condition: SCLC, limited (34) or extensive (12) disease
Demographics: men: 42, women: 4; median age (range): 57 (46‐71) years
Informed consent: unclear |
| Interventions |
Interventional treatment: thymostimulin; dose/schedule: 1 mg/kg/day; 1st cycle (d4‐10), 2nd‐4th cycle (d4‐6), 5th‐9th cycle (d4, 5)
Control treatment: no treatment
Basic treatment: methotrexate 40 mg/m² i.v. (d1), doxorubicin 40 mg/m² i.v. (d1), cyclophosphamide 400 mg/m² i.v. (d1), nitrosourea 30 mg/m² i.v., (d1); every 3 weeks; for 6 months or until progression |
| Outcomes |
Outcome measures: survival, response, toxicity (AEs of chemo‐/radiotherapy), other |
| Notes |
Participants: distribution of risk factors between groups not reported
Funding: thymostimulin supplied by Serono, Rome |
