Clinical trial NCT00293085: An Open, Randomized, Multicentre, Phase II Pilot Study
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Non-Small Cell Lung Cancer
Keywords: NSCLC
Docetaxel
Lead sponsor: Central European Cooperative Oncology Group
Sponsor class: OTHER
First posted: 2006-02-17
Enrollment: 37
Sex: ALL
Minimum age (years): 19
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 I-II.

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 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.

Eligibility criteria: 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

Primary outcomes:
measure: 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
Secondary outcomes:
measure: to determine the impact on overall survival of adjuvant docetaxel and cisplatin.
measure: to characterise and quantitate toxicity related to this treatment regimen.
measure: to compare quality of life of patients on both treatment arms.
Other outcomes:
Locations:
Study officials:
affiliation: Univ. Klinik f. Innere Medizin I
name: Christoph C. Zielinski, Prof
role: PRINCIPAL_INVESTIGATOR
References: