| Methods |
Design: 2‐arm parallel trial with a no‐treatment control group; stratification by histological type of disease and performance status
No of centers: 1
Recruitment and setting: M.D. Anderson Cancer Center, University of Texas, USA
Recruitment period: 01/79‐05/80
Observation period: max. 104 weeks
Ethical approval: unclear |
| Participants |
No. of patients: 105 randomised, 99 evaluated
Condition: advanced stage non‐small cell lung cancer (NSCLC)
Demographics: men: 70, women: 29; median age (range): IG: 55 (37‐77), CG: 57 (35‐80) years
Informed consent: yes |
| Interventions |
Interventional treatment: thymosin fraction 5; dose/schedule: 60 mg/m² s.c. every chemotherapy cycle (d1,4,8,12,16)
Control treatment: no treatment
Basic treatment: vindesine 3 mg/m² (d1), doxorubicin 50 mg/m² (d1), cisplatin 60 mg/m² (d1) every 3‐4 weeks |
| Outcomes |
Outcome measures: survival, response, toxicity (AEs of chemo‐/radiotherapy), safety (AEs of thymic peptides), chemotherapy dose/schedule modifications, other |
| Notes |
Participants: first 13 patients were not randomised because of unavailability of thymosin fraction 5 and allocated to the no‐treatment arm, thereafter to equalise the two arms a randomisation scheme favouring the thymosin arm was used
Outcomes: side effects of chemotherapy were not scored using standardized criteria
Funding: sponsored by the National Cancer Institute (NCI) |
