| Methods |
Design: 2‐arm parallel with placebo control
No. of centers: unclear
Recruitment and setting: unclear
Recruitment period: 04/89‐02/92
Observation period: approximately 5 months
Ethical approval: yes |
| Participants |
No. of patients: 69 randomised, 69 evaluated
Condition: NSCLC, stage IIIA and B
Demographics: men: 51, women: 18; age: patients under or 65 years: 39, patients over 65 years: 30
Informed consent: yes |
| Interventions |
Interventional treatment: thymostimulin; dose/schedule: 1 mg/kg; daily; after 2nd cycle: 3x/week, until end of treatment
Control treatment: placebo (not further described)
Basic treatment: radiochemotherapy: 24 fractions of 1.60 Gy 2x/day up to 38.4 G, followed within 14 days by one cycle of chemotherapy: carboplatin 250 mg/m² (d1), etoposide 100 mg/m² (d1), mitomycin C 8 mg/m² (d1‐3), followed within 14 days by radiotherapy: 12 fractions of 1.6 Gy 2x/day up to 19.2 Gy, thereafter 5 cycles of chemotherapy |
| Outcomes |
Outcome measures: toxicity (AEs of chemo‐/radiotherapy), other |
| Notes |
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