Combination Chemotherapy Combined With Radiation Therapy in Treating Patients Who Have Stage II or Stage III Cancer of the Esophagus
|ClinicalTrials.gov Identifier: NCT00008047|
Recruitment Status : Unknown
Verified February 2001 by National Cancer Institute (NCI).
Recruitment status was: Active, not recruiting
First Posted : January 27, 2003
Last Update Posted : February 9, 2009
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.
|Condition or disease||Intervention/treatment||Phase|
|Esophageal Cancer||Drug: fluorouracil Drug: hydroxyurea Drug: paclitaxel Procedure: conventional surgery Radiation: radiation therapy||Phase 1 Phase 2|
- 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 Type :||Interventional (Clinical Trial)|
|Masking:||None (Open Label)|
|Official Title:||Multicentre Phase II Study Of Concomitant Radio-Chemotherapy Associating Continuous Infusion 5-FU With Hydroxyuree Via Bone Marrow With Or Without Paclitaxel In Treatment Of Inoperable Epidermoid Carcinoma Of Esophagus|
|Study Start Date :||August 1999|
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00008047
|Amiens, France, 80054 Cedex 1|
|Clinique Saint Vincent|
|Besancon, France, 25044|
|Clinique Saint - Jean|
|Cagne-sur-Mer, France, 06800|
|CHR de Grenoble - La Tronche|
|Grenoble, France, F-38043|
|Hopital Andre Mignot|
|Le Chesnay, France, 78157|
|CMC Les Ormeaux|
|Le Havre, France, 76600|
|Centre Jean Bernard|
|Le Mans, France, 72000|
|Paris, France, 75007|
|Hopital Saint Antoine|
|Paris, France, 75571|
|Paris, France, 75970|
|Clinique Ste - Marie|
|Pontoise, France, 95301|
|Polyclinique De Courlancy|
|Reims, France, F-51100|
|Senlis, France, 60309|
|Tours, France, 37000|
|Study Chair:||Gerard Ganem, MD||Centre Jean Bernard|