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Sponsors and Collaborators: |
Cancer and Leukemia Group B National Cancer Institute (NCI) Radiation Therapy Oncology Group |
Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00002852 |
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. It is not yet known whether surgery is more effective with or without chemotherapy for non-small cell lung cancer.
PURPOSE: Randomized phase III trial to compare the effectiveness of surgery with or without combination chemotherapy in treating patients who have stage I non-small cell lung cancer.
Condition | Intervention | Phase |
Lung Cancer |
Drug: carboplatin Drug: paclitaxel Procedure: adjuvant therapy |
Phase III |
MedlinePlus related topics: | Cancer Lung Cancer |
ChemIDplus related topics: | Carboplatin Paclitaxel |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Active Control |
Official Title: | A PHASE III STUDY OF ADJUVANT CHEMOTHERAPY AFTER RESECTION FOR PATIENTS WITH T2N0 STAGE I NON-SMALL CELL CARCINOMA OF THE LUNG |
Estimated Enrollment: | 500 |
Study Start Date: | October 1996 |
OBJECTIVES:
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to tumor histology (squamous cell vs nonsquamous cell), degree of differentiation (poorly differentiated vs other), and mediastinal node sampling at surgery (yes vs no). Within 4-8 weeks after surgery, patients are randomized to 1 of 2 treatment arms.
Patients are followed every 4 months for 2 years and then every 6 months thereafter.
PROJECTED ACCRUAL: A total of 500 patients will be accrued for this study within 2.8 years.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically proven completely resected stage IB non-small cell lung cancer
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Show 297 Study Locations |
Cancer and Leukemia Group B |
National Cancer Institute (NCI) |
Radiation Therapy Oncology Group |
Study Chair: | Gary M. Strauss, MD | Rhode Island Hospital Comprehensive Cancer Center |
Study Chair: | David W. Johnstone, MD | James P. Wilmot Cancer Center |
Clinical trial summary from the National Cancer Institute's PDQ® database 
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Strauss GM, Herndon JE, Maddaus MA, et al.: Adjuvant chemotherapy in stage IB non-small cell lung cancer (NSCLC): update of Cancer and Leukemia Group B (CALGB) protocol 9633. [Abstract] J Clin Oncol 24 (Suppl 18): A-7007, 2006.
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Strauss GM, Herndon J, Maddaus MA, et al.: Randomized clinical trial of adjuvant chemotherapy with paclitaxel and carboplatin following resection in stage IB non-small cell lung cancer (NSCLC): report of Cancer and Leukemia Group B (CALGB) protocol 9633. [Abstract] J Clin Oncol 22 (Suppl 14): A-7019, 621s, 2004.
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Study ID Numbers: | CDR0000065095, CALGB-9633, RTOG-9616, CLB-C9633 |
First Received: | November 1, 1999 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00002852 |
Health Authority: | United States: Federal Government |
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