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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 Surgery With or Without Preoperative Chemotherapy in Patients With Resectable Non-Small Cell Lung Cancer

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase III	Treatment	Closed	Any age	Other	MRC-LU22 EORTC-08012, EU-97016, ISRCTN25582437, NCT00003159

Trial Description

Purpose:

Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known if surgery is more effective with or without preoperative chemotherapy in treating non-small cell lung cancer.

This randomized phase III trial is studying surgery and preoperative chemotherapy to see how well they work compared to surgery alone in treating patients with resectable non-small cell lung cancer.

Eligibility:

Eligibility criteria include the following:

• Any age
• No distant metastases
• No previous treatment
• 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 undergo surgery to remove the tumor. Patients in group two will receive one of six combination chemotherapy regimens every 3 weeks for three courses. They will undergo surgery at least 4 weeks after the last course of chemotherapy. Quality of life will be assessed at 6 and 12 months and once a year thereafter. Patients will be evaluated 1 month after surgery and every 3-6 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

Medical Research Council Clinical Trials Unit

Adrian Hodson, Study coordinator		Ph: 44-20-7670-4735

European Organization for Research and Treatment of Cancer

Ian Smith, MD, Study coordinator		Ph: 44-20-7808-2751 Email: ian.smith@rmh.nhs.uk

Registry Information
Official Title		Randomized Trial of Surgical Resection with or without Pre-Operative Chemotherapy in Patients with Operable Non-Small Cell Lung Cancer (NSCLC) of Any Stage
Trial Start Date		1997-08-01
Registered in ClinicalTrials.gov		NCT00003159
Date Submitted to PDQ		1997-12-11
Information Last Verified		2005-05-27

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