Status:
COMPLETED
An Open, Randomized, Multicentre, Phase II Pilot Study
Lead Sponsor:
Central European Cooperative Oncology Group
Conditions:
Non-Small Cell Lung Cancer
Eligibility:
All Genders
19-70 years
Phase:
PHASE2
Brief Summary
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 ...
Detailed Description
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 d...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2001
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2003
Estimated Enrollment :
37 Patients enrolled
Trial Details
Trial ID
NCT00293085
Start Date
December 1 2001
End Date
September 1 2003
Last Update
June 23 2011
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