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Alternate Title
Basic Trial Information
Trial Description
     Purpose
     Eligibility
     Treatment/Intervention
Trial Contact Information
Registry Information

Alternate Title

Phase III Randomized Study of Paclitaxel and Carboplatin Versus No Adjuvant Chemotherapy After Resection in Patients With Stage IB Non-Small Cell Lung Cancer

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase III	Treatment	Closed	18 and over	NCI	CALGB-9633 RTOG-9616, CLB-C9633, NCT00002852

Special Category: CTSU trial

Trial Description

Purpose:

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.

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.

Eligibility:

• At least 18 years old
• No more than 4-8 weeks since surgery to remove the tumor
• No previous chemotherapy or radiation therapy
• For more information about the eligibility criteria for this trial, refer to the Health Professional version.

Final eligibility for a clinical trial is determined by the health professionals conducting the trial.

Treatment/Intervention:

Patients will be randomly assigned to one of two groups. Patients in group one will receive no further therapy following surgery. Patients in group two will receive infusions of carboplatin and paclitaxel every 3 weeks for four courses. Patients will receive follow-up examinations every 4 months for 2 years and every 6 months thereafter.

Important:

For more details about this trial, refer to the Health Professional version of the trial summary.

If you are interested in participating in a clinical trial, contact your doctor for a referral or call a trial contact person listed below. You may see the same contact person listed at more than one site, however, if you call the number listed you can ask to speak to the study coordinator or person involved with the specific trial you are interested in. If you have questions about cancer or clinical trials, call the Cancer Information Service at 1-800-4-CANCER (1-800-422-6237). General information about clinical trials, including risks, benefits, and costs, can be found on NCI's Web site.

Trial Contact Information

Trial Lead Organizations

Cancer and Leukemia Group B

Gary Strauss, MD, Protocol chair		Ph: 401-444-5391 Email: gstrauss@lifespan.org

Radiation Therapy Oncology Group

David Johnstone, MD, Protocol chair		Ph: 585-275-1509 Email: david_johnstone@urmc.rochester.edu

Registry Information
Official Title		A PHASE III STUDY OF ADJUVANT CHEMOTHERAPY AFTER RESECTION FOR PATIENTS WITH T2N0 STAGE I NON-SMALL CELL CARCINOMA OF THE LUNG
Trial Start Date		1996-10-15
Registered in ClinicalTrials.gov		NCT00002852
Date Submitted to PDQ		1996-10-15
Information Last Verified		2003-12-10
NCI Grant/Contract Number		CA31946