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

NCT ID: NCT00008047

Last Updated: 2009-02-09

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1/PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 1999-08-31

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.

Conditions

Esophageal Cancer

Study Design

• Allocation Method: RANDOMIZED
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

fluorouracil

Intervention Type: DRUG

hydroxyurea

Intervention Type: DRUG

paclitaxel

Intervention Type: DRUG

conventional surgery

Intervention Type: PROCEDURE

radiation therapy

Intervention Type: RADIATION

Eligibility Criteria

Inclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

GERCOR - Multidisciplinary Oncology Cooperative Group

OTHER

Sponsor Role: lead

Principal Investigators

Gerard Ganem, MD

Role: STUDY_CHAIR

Centre Jean Bernard

Locations

Hopital Saint-Louis

Amiens, , France

Clinique Saint Vincent

Besançon, , 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

Clinique Ste - Marie

Pontoise, , France

Polyclinique De Courlancy

Reims, , France

C.H. Senlis

Senlis, , France

Clinique Fleming

Tours, , France

Countries

France

Other Identifiers

FRE-GERCOR-D99-1

Identifier Type: -

Identifier Source: secondary_id

EU-20021

Identifier Type: -

Identifier Source: secondary_id

CDR0000068368

Identifier Type: -

Identifier Source: org_study_id