Combination Chemotherapy Combined With Radiation Therapy in Treating Patients Who Have Stage II or Stage III Cancer of the Esophagus

Phase 1

• Conditions: Esophageal Cancer

• Registration Number: NCT00008047
• Lead Sponsor: GERCOR - Multidisciplinary Oncology Cooperative Group

Brief Summary

RATIONALE: Drugs used in chemotherapy 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 more than one chemotherapy drug with radiation therapy may kill more tumor cells.

PURPOSE: Randomized phase I/II trial to study the effectiveness of combination chemotherapy with or without paclitaxel combined with radiation therapy in treating patients who have stage II or stage III cancer of the esophagus.

Detailed Description

OBJECTIVES:

* Compare the efficacy of concurrent radiotherapy with fluorouracil and hydroxyurea with or without paclitaxel in terms of survival without dysphagia in patients with inoperable stage II or III epidermoid carcinoma of the esophagus.

* Compare the overall survival, response rate, toxicity, and quality of life in this patient population treated with these regimens.

OUTLINE: This is a randomized, open label, multicenter study. Patients are stratified according to weight loss (less than 10% vs at least 10%) and inoperability criteria (nonresectable vs due to anatomical terrain). Patients are randomized to one of two treatment arms.

* Arm I: Patients receive fluorouracil IV continuously, oral hydroxyurea, and concurrent radiotherapy daily on days 1-5.

* Arm II: Patients receive fluorouracil, hydroxyurea and radiotherapy as in arm I. Patients also receive paclitaxel IV on day 1.

Treatment continues every 2 weeks for 4 courses in the absence of disease progression or unacceptable toxicity.

Patients with possible resectable disease undergo surgical resection at 4-6 weeks following the last course of chemoradiotherapy. Patients with continued unresectable disease receive 2 additional courses of chemoradiotherapy as above within 8-17 days following the last course of chemoradiotherapy.

Quality of life is assessed at baseline, monthly during therapy, every 2 months for 6 months, every 4 months for 1 year, and then every 6 months thereafter.

Patients are followed every 2 months for 6 months, every 4 months for 1 year, and then every 6 months thereafter.

PROJECTED ACCRUAL: A maximum of 90 patients will be accrued for this study.

Study Timeline

• Study Start: 1999-08
• Study First Submitted: 2001-01-06
• Status Verified: 2001-02
• Study First Submitted QC: 2003-01-26
• Study First Posted: 2003-01-27
• Last Update Submitted: 2009-02-06
• Last Update Posted: 2009-02-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Trial Locations

Locations (14)

Hopital Saint-Louis; 🇫🇷 Amiens, France

Clinique Saint Vincent; 🇫🇷 Besancon, France

Clinique Saint - Jean; 🇫🇷 Cagne-sur-Mer, France

CHR de Grenoble - La Tronche; 🇫🇷 Grenoble, France

Hopital Andre Mignot; 🇫🇷 Le Chesnay, France

CMC Les Ormeaux; 🇫🇷 Le Havre, France

Centre Jean Bernard; 🇫🇷 Le Mans, France

Hopital Laennec; 🇫🇷 Paris, France

Hopital Saint Antoine; 🇫🇷 Paris, France

Hopital Tenon; 🇫🇷 Paris, France

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