| Methods |
Design: 3‐arm parallel with placebo control
No of centres: unclear
Recruitment and setting: NCI‐VA Medical Oncology Branch, Veterans Administration Hospital, Washington, D.C.; Surgery Branch, National Cancer Institute, Bethesda, USA
Recruitment period: 07/75‐01/77
Observation period: approximately 2 years for survival, 12 weeks for response
Ethical approval: unclear |
| Participants |
No. of patients: 55 randomised, 46 evaluated
Condition: small cell lung cancer (SCLC), limited (15) or extensive (31) disease
Demographics: men: 34, women: 12; median age (range): IG1: 58 (49‐69), IG2: 61 (47‐69), CG: 53 (41‐67) years
Informed consent: yes |
| Interventions |
Interventional treatment: thymosin fraction 5; dose/schedule: IG1: 60 mg/m² s.c., IG2: 20 mg/m² s.c., 2x/week during induction chemotherapy
Control treatment: no treatment
Basic treatment: induction therapy: cyclophosphamide 1500 mg/m² (d1), lomustine 100 mg/m² (d1), cyclophosphamide 1000 mg/m² (d22), methotrexate 15 mg/m² 2x/week for 10 doses; maintenance therapy: cyclically alternating two or three drug chemotherapy regimes for 2 years; starting on week 6 |
| Outcomes |
Outcome measures: survival, response, toxicity (AEs of chemo‐/radiotherapy), safety (AEs of thymic peptides), other |
| Notes |
Participants: as stated by study authors patients in the IG2 tended to have a lower performance status
Outcomes: side effects of chemotherapy were not scored using standardized criteria
ITT analysis: was performed
Funding: thymosin fraction 5 was provided by Hoffmann‐La Roche |
