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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 Neoadjuvant Radio-Chemotherapy and Surgery Versus Surgery Alone in Patients With Resectable Thoracic Esophageal Cancer

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase III	Treatment	Closed	Under 75	Other	FFCD-9901 EORTC-22001, EORTC-40001, FRE-FNCLCC-FFCD-9901, FRE-GERCOR-FFCD-9901, SFRO-FFCD-9901, EU-20215, NCT00047112

Trial Description

Purpose:

Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Giving combination chemotherapy with radiation therapy before surgery may shrink the tumor so it can be removed during surgery. It is not yet known if surgery is more effective with or without radiation therapy and chemotherapy in treating esophageal cancer.

Randomized phase III trial to compare the effectiveness of surgery with or without radiation therapy and chemotherapy in treating patients who have esophageal cancer.

Eligibility:

Eligibility criteria include the following:

• Younger than 75 years old
• No previous treatment for this cancer
• 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 radiation therapy once a day 5 days a week for 5 weeks. They will also receive a 4-day continuous infusion of fluorouracil and an infusion of cisplatin for 1-5 days in weeks 1 and 5. Within 4-8 weeks after radiation therapy and chemotherapy, patients will undergo surgery to remove the tumor. Patients in group two will undergo surgery alone. All patients will be evaluated every 4 months for 2 years, every 6 months for 3 years, and once a year 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

Federation Francophone de Cancerologie Digestive

J. Triboulet, Protocol chair		Ph: 33-3-20-44-42-04

GERCOR Groupe Cooperateur Multidisciplinaire en Oncologie

Gerard Ganem, MD, Protocol chair		Ph: 334-339-1300

European Organization for Research and Treatment of Cancer

Jean-Francois Bosset, MD, Study coordinator		Ph: 33-381-668310 Email: jean-francois.bosset@ufc-chu.univ-fcomte.fr
Thierry Conroy, MD, Study coordinator		Ph: 33-3-8359-8460

Federation Nationale des Centres de Lutte Contre le Cancer

Jean-Francois Seitz, MD, Protocol chair		Ph: 33-4-9122-3302

Societe Francaise de Radiotherapie Oncologique

Francoise Mornex, MD, PhD, Protocol chair		Ph: 33-478-864-253 Email: francoise.mornex@chu-lyon.fr

Registry Information
Official Title		Randomized Study of Pre-Operative Radio-Chemotherapy Versus Surgery Alone in Thoracic Esophageal Cancer Deemed to be Resectable
Trial Start Date		2002-05-17
Registered in ClinicalTrials.gov		NCT00047112
Date Submitted to PDQ		2002-07-10
Information Last Verified		2005-02-23

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