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

Alternate Title

Phase II Study of Paclitaxel, Fluorouracil, and Cisplatin Followed By Chemoradiotherapy and Possible Surgical Salvage in Patients With Resectable Locally Advanced Carcinoma of the Esophagus or Gastroesophageal Junction

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Closed	18 and over	NCI	RTOG-0246 NCT00069953

Trial Description

Purpose:

Drugs used in chemotherapy such as paclitaxel, fluorouracil, and cisplatin use 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. Combining chemotherapy with radiation therapy may kill more tumor cells

This phase II trial is studying how well combination chemotherapy followed by chemoradiotherapy, with or without surgery, works in treating patients with resectable locally advanced cancer of the esophagus or gastroesophageal junction.

Eligibility:

Eligibility criteria include the following:

• At least 18 years old
• No metastatic cancer
• More than 5 years since chemotherapy
• No previous radiation therapy to the chest or upper abdomen
• No previous surgery to the esophagus or stomach
• 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:

In week 1, patients will receive a 4-day continuous infusion of fluorouracil, a 1-hour infusion of cisplatin for 5 days, and a 2-hour infusion of paclitaxel. Treatment will be repeated in week 5. They will also receive either an injection of pegfilgrastim in weeks 1 and 5 or filgrastim beginning in weeks 1 and 5 and continuing for up to 10 days .

In week 9, patients will receive a 1-hour infusion of cisplatin for 5 days. They will also receive 5-day continuous infusions of fluorouracil and undergo radiation therapy 5 days a week for 6 weeks.

Some patients may undergo surgery within 4 to 6 weeks after completing chemoradiotherapy.

Patients will be evaluated periodically.

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

Radiation Therapy Oncology Group

Stephen Swisher, MD, Protocol chair		Ph: 713-792-8659; 800-392-1611

Registry Information
Official Title		A Phase II Study Of Paclitaxel-Based Chemoradiotherapy Regimen With Selective Surgical Salvage For Resectable Locoregionally Advanced Carcinoma Of The Esophagus
Trial Start Date		2003-09-05
Registered in ClinicalTrials.gov		NCT00069953
Date Submitted to PDQ		2003-05-16
Information Last Verified		2006-02-15
NCI Grant/Contract Number		CA21661

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