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Phase III Randomized Study of Paclitaxel and Carboplatin Versus No Adjuvant Chemotherapy After Resection in Patients With Stage IB Non-Small Cell Lung Cancer
Alternate Title Surgery With or Without Chemotherapy in Treating Patients With Stage I Non-small Cell Lung Cancer
Special Category: CTSU trial Objectives
Entry Criteria Disease Characteristics:
Prior/Concurrent Therapy: Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Patient Characteristics: Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
Expected Enrollment 500A total of 500 patients will be accrued for this study within 2.8 years. 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. Published ResultsStrauss GM, Herndon JE 2nd, Maddaus MA, et al.: Adjuvant paclitaxel plus carboplatin compared with observation in stage IB non-small-cell lung cancer: CALGB 9633 with the Cancer and Leukemia Group B, Radiation Therapy Oncology Group, and North Central Cancer Treatment Group Study Groups. J Clin Oncol 26 (31): 5043-51, 2008.[PUBMED Abstract] 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. 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. Related PublicationsClose JL, Daniels L, Allegra CJ, et al.: Impact of 2006 ASCO Annual Meeting data release of Cancer and Leukemia Group B (CALGB) protocol 9633 on practice patterns in the United States. [Abstract] J Clin Oncol 26 (Suppl 15): A-7547, 2008. Kassam F, Shepherd FA, Johnston M, et al.: Referral patterns for adjuvant chemotherapy in patients with completely resected non-small cell lung cancer. J Thorac Oncol 2 (1): 39-43, 2007.[PUBMED Abstract] Hotta K, Matsuo K, Kiura K, et al.: Advances in our understanding of postoperative adjuvant chemotherapy in resectable non-small-cell lung cancer. Curr Opin Oncol 18 (2): 144-50, 2006.[PUBMED Abstract] Wakelee HA, Schiller JH, Gandara DR: Current status of adjuvant chemotherapy for stage IB non-small-cell lung cancer: implications for the New Intergroup Trial. Clin Lung Cancer 8 (1): 18-21, 2006.[PUBMED Abstract] Visbal AL, Leighl NB, Feld R, et al.: Adjuvant Chemotherapy for Early-Stage Non-small Cell Lung Cancer. Chest 128 (4): 2933-43, 2005.[PUBMED Abstract] Trial Lead Organizations Cancer and Leukemia Group B
Radiation Therapy Oncology Group
Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol. |
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