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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

Phase 2
19 Years
70 Years
Not Enrolling
Non-Small Cell Lung Cancer

Thank you

Trial Information

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.

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

- major complications after surgery

- serious concomitant medical conditions

- psychological,familial, sociological or geographical conditions which do not permit
compliance with the study protocol

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome 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

Principal Investigator

Christoph C. Zielinski, Prof

Investigator Role:

Principal Investigator

Investigator Affiliation:

Univ. Klinik f. Innere Medizin I


Austria: Federal Ministry for Health and Women

Study ID:

CECOG/ NSCLC 2.2.001



Start Date:

December 2001

Completion Date:

September 2003

Related Keywords:

  • Non-Small Cell Lung Cancer
  • Docetaxel
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms