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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. 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
Information provided by:
National Cancer Institute (NCI)

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.

Condition or disease Intervention/treatment Phase
Esophageal Cancer Drug: fluorouracil Drug: hydroxyurea Drug: paclitaxel Procedure: conventional surgery Radiation: radiation therapy Phase 1 Phase 2

Detailed Description:


  • 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)
Allocation: Randomized
Masking: None (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

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U.S. FDA Resources

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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



  • 18 to 80

Performance status:

  • ECOG 0-2

Life expectancy:

  • Not specified


  • 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


  • SGOT and SGPT no greater than 2 times normal
  • Albumin at least 3.0 g/dL


  • Creatinine no greater than 1.4 mg/dL
  • Calcium less than 11.2 mg/dL


  • See Disease Characteristics
  • No severe respiratory illness (e.g., severe broncho-pathway obstruction or insufficient respiration)
  • No uncontrolled broncho-pulmonary infection


  • 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


Biologic therapy:

  • No prior biologic therapy


  • No prior chemotherapy

Endocrine therapy:

  • No prior endocrine therapy


  • No prior radiotherapy


  • See Disease Characteristics


  • No concurrent participation in other study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00008047

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 Laennec
Paris, France, 75007
Hopital Saint Antoine
Paris, France, 75571
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
Sponsors and Collaborators
GERCOR - Multidisciplinary Oncology Cooperative Group
Study Chair: Gerard Ganem, MD Centre Jean Bernard Identifier: NCT00008047     History of Changes
Other Study ID Numbers: CDR0000068368
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: February 9, 2009
Last Verified: February 2001

Keywords provided by National Cancer Institute (NCI):
stage II esophageal cancer
stage III esophageal cancer

Additional relevant MeSH terms:
Esophageal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antisickling Agents
Enzyme Inhibitors
Nucleic Acid Synthesis Inhibitors