An Open, Randomized, Multicentre, Phase II Pilot Study of Docetaxel and Cisplatin in the Adjuvant Treatment of Non-Small Cell Lung Cancer (NSCLC) Stage I-II
Open multicentre, centrally randomized, two-arm parallel-group, phase II pilot-study.
Duration of the Treatment : Arm A - will be 4-6 cycles Docetaxel 75mg/m2 and Cisplatin
75mg/m2 on day 1 every 21 days.
Arm B untreated control group - best supportive care. A follow-up check-up examination will
be performed every 3 months for a total of three years.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
to compare the effect on disease free survival of adjuvant docetaxel and cisplatin in patients with completely resected stage I-II non-small cell lung cancer versus observation only
Christoph C. Zielinski, Prof
Univ. Klinik f. Innere Medizin I
Austria: Federal Ministry for Health and Women
CECOG/ NSCLC 2.2.001