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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, Carboplatin, and Radiotherapy With or Without Adjuvant Paclitaxel and Carboplatin in Patients With Stage II or III Unresectable Non-Small Cell Lung Cancer

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase III	Treatment	Closed	18 to 79	Other	FRE-GERCOR-B00-1 EU-20330, NCT00077220

Trial Description

Purpose:

Drugs used in chemotherapy, such as paclitaxel and carboplatin, work in different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. It is not yet known whether giving chemotherapy together with radiation therapy is more effective with or without adjuvant chemotherapy in treating unresectable stage II or stage III non-small cell lung cancer.

This randomized phase III trial is studying giving paclitaxel, carboplatin, and radiation therapy together with adjuvant paclitaxel and carboplatin to see how well it works compared to giving paclitaxel, carboplatin, and radiation therapy alone in treating patients with unresectable stage II or stage III non-small cell lung cancer.

Eligibility:

Eligibility criteria include the following:

• 18-79 years old
• Measurable or evaluable disease
• More than 6 months since neoadjuvant chemotherapy
• No previous adjuvant chemotherapy
• No previous 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 receive an infusion of carboplatin and a 1-hour infusion of paclitaxel once a week for up to 6 weeks. At the same time, they will undergo radiation therapy 5 days a week for up to 7.5 weeks. Three weeks after completing chemotherapy and radiation therapy, patients may be randomly assigned to one of two groups.

Patients in group one will receive standard follow-up care. Patients in group two will receive an infusion of carboplatin and a 3-hour infusion of paclitaxel every 3 weeks for up to three courses.

Patients will be evaluated every 3 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

GERCOR Groupe Cooperateur Multidisciplinaire en Oncologie

Jean Morere, MD, Study coordinator		Ph: 33-1-48-955-032

Registry Information
Official Title		Phase III Randomised Study Of Adjuvant Paclitaxel And Carboplatin (TAXOL-PARAPLATINE) With Concomittant Radiotherapy In Patients With Stage II or III Non-Metastatic Non-Small Cell Lung Cancer
Trial Start Date		2002-06-12
Registered in ClinicalTrials.gov		NCT00077220
Date Submitted to PDQ		2003-12-16
Information Last Verified		2007-05-17

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