Combination Chemotherapy Combined With Radiation Therapy in Treating Patients Who Have Stage II or Stage III Cancer of the Esophagus
Recruitment status was Active, not recruiting
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Esophageal Cancer |
Drug: fluorouracil Drug: hydroxyurea Drug: paclitaxel Procedure: conventional surgery Radiation: radiation therapy |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Masking: Open Label Primary Purpose: Treatment |
| 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 |
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.
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
- Histologically confirmed stage II (T2 or T3, N0, M0) or III (T3, N1, M0) epidermoid carcinoma of the esophagus
- Inoperable due to initial extension or inoperable with no extension
- No visceral metastases
No extension to the tracheo-bronchial pathway
- No tracheo-esophageal fistula
- No broncho-esophageal fistula
- No suspected respiratory mucosal involvement on bronchoscopy
- No carcinoma in situ
PATIENT CHARACTERISTICS:
Age:
- 18 to 80
Performance status:
- ECOG 0-2
Life expectancy:
- Not specified
Hematopoietic:
- Platelet count at least 120,000/mm^3
- Hemoglobin at least 10 g/dL
- Neutrophil count at least 1,500/mm^3
- Lymphocyte count at least 1,000/mm^3
Hepatic:
- SGOT and SGPT no greater than 2 times normal
- Albumin at least 3.0 g/dL
Renal:
- Creatinine no greater than 1.4 mg/dL
- Calcium less than 11.2 mg/dL
Pulmonary:
- See Disease Characteristics
- No severe respiratory illness (e.g., severe broncho-pathway obstruction or insufficient respiration)
- No uncontrolled broncho-pulmonary infection
Other:
- No other prior history of malignancy except curatively treated carcinoma in situ of the colon or skin cancer
- No contraindication to fluorouracil
- Not pregnant or nursing
- Fertile patients must use effective contraception
- No psychiatric illness
- HIV negative
- Total protein at least 65% of normal
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- No prior biologic therapy
Chemotherapy:
- No prior chemotherapy
Endocrine therapy:
- No prior endocrine therapy
Radiotherapy:
- No prior radiotherapy
Surgery:
- See Disease Characteristics
Other:
- No concurrent participation in other study
Contacts and Locations| France | |
| Hopital Saint-Louis | |
| 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 | |
| Hopital Saint Antoine | |
| Paris, France, 75571 | |
| Hopital Laennec | |
| Paris, France, 75007 | |
| Hopital Tenon | |
| Paris, France, 75970 | |
| Clinique Ste - Marie | |
| Pontoise, France, 95301 | |
| Polyclinique De Courlancy | |
| Reims, France, F-51100 | |
| C.H. Senlis | |
| Senlis, France, 60309 | |
| Clinique Fleming | |
| Tours, France, 37000 | |
| Study Chair: | Gerard Ganem, MD | Centre Jean Bernard |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00008047 History of Changes |
| Other Study ID Numbers: | CDR0000068368, FRE-GERCOR-D99-1, EU-20021 |
| Study First Received: | January 6, 2001 |
| Last Updated: | February 6, 2009 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
|
stage II esophageal cancer stage III esophageal cancer |
Additional relevant MeSH terms:
|
Carcinoma, Squamous Cell Esophageal Diseases Esophageal Neoplasms Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Neoplasms, Squamous Cell Gastrointestinal Diseases Digestive System Diseases Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Head and Neck Neoplasms Fluorouracil |
Hydroxyurea Paclitaxel Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antimetabolites, Antineoplastic Antineoplastic Agents Therapeutic Uses Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Antisickling Agents Hematologic Agents Enzyme Inhibitors Nucleic Acid Synthesis Inhibitors |
ClinicalTrials.gov processed this record on May 19, 2013