Phase II Trial of Gemcitabine and Cisplatin as Neo-Adjuvant Chemotherapy for Operable Non-Small Cell Lung Cancer
Phase 2
18 Years
70 Years
18 Years
70 Years
Not Enrolling
Both
Carcinoma, Non-Small-Cell-Lung Cancer
Both
Carcinoma, Non-Small-Cell-Lung Cancer
Trial Information
Phase II Trial of Gemcitabine and Cisplatin as Neo-Adjuvant Chemotherapy for Operable Non-Small Cell Lung Cancer
Inclusion Criteria:
- define histologic or cytologic diagnosis of non small cell lung cancer.
- determine the presence of clinical Stage IB, IIA-B or IIIA disease in accordance with
the revision by Mountain CF of American Joint Committee on Cancer.
- define performance status of 0-1 on ECOG scale
- do not have any prior tumor therapy
- to be suitable for curative resection
Exclusion Criteria:
- to have any treatment within the last 30 days with any investigational drug.
- to get concurrent administration of any other tumor therapy
- to be pregnant
- to have poorly controlled diabetes mellitus
- to have serious concomitant disorders.
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
To evaluate the clinical response rate of neo-adjuvant chemotherapy with gemcitabine and cisplatin in patients with operable non small cell lung cancer
Principal Investigator
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern Time (UTC/GMT - 5 hours, EST)
Investigator Role:
Study Director
Investigator Affiliation:
Eli Lilly and Company
Authority:
Turkey: Ministry of Health
Study ID:
7138
NCT ID:
NCT00191763
Start Date:
November 2002
Completion Date:
December 2005
Related Keywords:
- Carcinoma, Non-Small-Cell-Lung Cancer
- Carcinoma
- Carcinoma, Non-Small-Cell Lung
- Lung Neoplasms
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