NCT00008047

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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

14 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 1999

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

January 6, 2001

Completed
2.1 years until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
Last Updated

February 9, 2009

Status Verified

February 1, 2001

First QC Date

January 6, 2001

Last Update Submit

February 6, 2009

Conditions

Esophageal Cancer

Keywords

stage II esophageal cancerstage III esophageal cancer

Interventions

fluorouracilDRUG
hydroxyureaDRUG
paclitaxelDRUG
conventional surgeryPROCEDURE
radiation therapyRADIATION

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (14)

Hopital Saint-Louis

Amiens, 80054 Cedex 1, France

Location

Clinique Saint Vincent

Besançon, 25044, France

Location

Clinique Saint - Jean

Cagne-sur-Mer, 06800, France

Location

CHR de Grenoble - La Tronche

Grenoble, F-38043, France

Location

Hopital Andre Mignot

Le Chesnay, 78157, France

Location

CMC Les Ormeaux

Le Havre, 76600, France

Location

Centre Jean Bernard

Le Mans, 72000, France

Location

Hopital Laennec

Paris, 75007, France

Location

Hopital Saint Antoine

Paris, 75571, France

Location

Hopital Tenon

Paris, 75970, France

Location

Clinique Ste - Marie

Pontoise, 95301, France

Location

Polyclinique De Courlancy

Reims, F-51100, France

Location

C.H. Senlis

Senlis, 60309, France

Location

Clinique Fleming

Tours, 37000, France

Location

MeSH Terms

Conditions

Esophageal Neoplasms

Interventions

FluorouracilHydroxyureaPaclitaxelRadiotherapy

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsHead and Neck NeoplasmsDigestive System DiseasesEsophageal DiseasesGastrointestinal Diseases

Intervention Hierarchy (Ancestors)

UracilPyrimidinonesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsUreaAmidesOrganic ChemicalsTaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsDiterpenesTerpenesTherapeutics

Study Officials

  • Gerard Ganem, MD

    Centre Jean Bernard

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 6, 2001

First Posted

January 27, 2003

Study Start

August 1, 1999

Last Updated

February 9, 2009

Record last verified: 2001-02

Locations

FR(14)