| Methods |
Design: 2‐arm parallel trial with a no‐treatment control group; patients stratified by performance status and disease extent
No. of centres: 2
Recruitment and setting: Memorial Sloan‐Kettering Cancer Center, Cornell University Medical College, New York, USA
Recruitment period: 05/79‐ 05/82
Observation period: approximately 25 to 60 months
Ethical approval: unclear |
| Participants |
No. of patients: 91 randomised, 80 evaluated
Condition: SCLC limited (32) or and extensive disease (48)
Demographics: men: 59, women: 32; median age (range): IG: 59 (35‐73), CG: 53 (32‐72) years
Informed consent: unclear |
| Interventions |
Interventional treatment: thymosin fraction 5; dose/schedule: 60 mg/m² s.c.; 2x/week from the start of induction therapy through the completion of radiotherapy
Control treatment: no treatment
Basic treatment: induction therapy: 1st and 3rd cycle: cyclophosphamide 1200 mg/m² (d1), doxorubicin 50 mg/m² (d1), vincristine 1.2 mg/m² (d1, 8); 2nd and 4th cycle: cisplatin 60 mg/m² (d1) and etoposide 120 mg/m² (d4, 6, 8); consolidation therapy: cyclophosphamide 500 mg/m² (d1,14), vincristine 1,4 mg/m² (d1,14) along with radiation therapy in patients with limited disease; maintenance therapy was started 10 weeks after completion of radiotherapy in patients who had achieved complete remission, others started after hematologic recovery: 1st cycle: lomustine 60 mg/m² p.o. (d1), methotrexate 30 mg/week for 4 weeks, procarbazine 100 mg/m² p.o. (d1‐14); 2nd cycle cyclophosphamide 1000 mg/m² (d42) and doxorubicin 30 mg/m²(d42); 3rd cycle: vincristine 1,2 mg/m² d63, cisplatin 50 mg/m² d63 and etoposide 120 mg/m² (d67, 69, 71); radiotherapy with 2.5 Gy/day up to 45 Gy to primary site and anterior mediastinum (patients with LD); 3 Gy/day up to 30 Gy whole brain radiation (all patients) |
| Outcomes |
Outcome measures: survival, response, toxicity (AEs of chemo‐/radiotherapy), safety (AEs of thymic peptides), other |
| Notes |
Method: sample size calculation was performed, accordingly 80 patients would be required in order to detect a 25% increase in complete remission rate
Funding: supported in part by the American Cancer Society and the National Institutes of Health (NIH); thymosin fraction 5 was supplied by Hoffmann‐La Roche |
