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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 Surgical Resection with vs without Neoadjuvant Fluorouracil/Cisplatin for Adenocarcinoma of the Lower Third of the Esophagus or the Cardia

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase III	Treatment	Closed	Under 76	Other	FRE-FNCLCC-94012 EU-96018, NCT00002883

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 known whether combining chemotherapy with surgery is more effective than surgery alone.

Randomized phase III trial to compare the effectiveness of surgery with or without combination chemotherapy in treating patients with cancer of the esophagus.

Eligibility:

• Younger than 76 years old
• No distant metastases
• 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 randomized to one of two groups. Patients in group one will undergo surgery to remove the tumor and lymph nodes near the tumor. Patients in group two will receive infusions of fluorouracil and cisplatin for 5 days every 3-4 weeks for up to three courses, followed by surgery. Patients in group two may receive up to six courses of chemotherapy beginning 3-6 weeks afer surgery. Some patients may receive radiation therapy. Patients will receive follow-up evaluations every 3-4 months for at least 5 years.

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

Federation Nationale des Centres de Lutte Contre le Cancer

Marc Ychou, MD, PhD, Protocol chair		Ph: 33-4-6761-3066 Email: mychou@valdorel.fnclcc.fr

Registry Information
Official Title		A PROSPECTIVE RANDOMISED TRIAL OF INDUCTION CHEMOTHERAPY WITH 5-FU CONTINUOUS IV INFUSION AND CISPLATIN VERSUS SURGERY IN RESECTABLE ADENOCARCINOMA OF THE LOW THIRD OF THE ESOPHAGUS AND CARDIOESOPHAGEAL JUNCTION
Trial Start Date		1996-10-04
Registered in ClinicalTrials.gov		NCT00002883
Date Submitted to PDQ		1996-10-04
Information Last Verified		2001-04-27

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