An Open, Randomized, Multicentre, Phase II Pilot Study

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

The objective of this study is to evaluate efficacy, safety and quality of life adjuvant docetaxel-cisplatin chemotherapy versus no adjuvant treatment in patients with completely resected 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.

Inclusion Criteria:

• histologically documented NSCLC stage I-II
• Complete resection of tumor amd resection margins microscopically tumor free.
• Surgical procedure: According to necessity for oncology radicality a lobectomy, bilobectomy or pneumectomy will be performed with either radical mediastinal lymphadenectomy or complete sampling of all relevant lymph node areas.
• Randomization within 60 days after surgical required.
• Initial work-up
• General Conditions: 19-70 years, WHO performance status 0-2, adequate hematological function, adequate renal and hepatic function, negative pregnancy test.

Exclusion Criteria:

• NSCLC stage II-IV, SCLC or alveolar carcinoma
• Clinical evidence of CNS metastases
• pregnant and lactating patients
• past or concurrent history of malignancies other than NSCLC,except for curatively treated non melanoma of the skin or in situ cervical carcinoma or other curatively treated cancer with no evidence of disease for at least five years.
• prior or concurrent antitumor therapy for NSCLC other than surgery.
• Concomitant participation in clinical studies of non-approved experimental agents or procedures.
• major complications after surgery
• serious concomitant medical conditions
• psychological,familial, sociological or geographical conditions which do not permit compliance with the study protocol