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Chemotherapy and Radiation Therapy in Treating Patients With Cancer of the Esophagus

NCT ID: NCT00002884

Last Updated: 2013-08-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

326 participants

Study Classification

INTERVENTIONAL

Study Start Date

1996-03-31

Brief Summary

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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. It is not yet known whether external-beam radiation therapy plus chemotherapy is more effective with or without internal radiation therapy.

PURPOSE: Randomized phase III trial to compare chemotherapy and external-beam radiation therapy with or without internal radiation therapy in treating patients with stage I, stage II, or stage III esophageal cancer.

Detailed Description

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OBJECTIVES: I. Compare the complete local remission rate in patients with unresectable stage I, II, or III esophageal cancer treated with chemoradiotherapy with or without endoluminal brachytherapy. II. Compare the complete remission rate (local, locoregional, and distant) in these patients. III. Compare the overall and disease-free survival in these patients at 2 and 5 years after therapy. IV. Compare the toxicity and quality of life experienced by these patients.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to participating center, tumor stage, and chemotherapy. All patients receive fluorouracil IV continuously over 4 days (days 1-4) and/or cisplatin on day 2 of weeks 1 and 5. External beam radiotherapy begins on day 1 of chemotherapy and is delivered in daily fractions, 5 days per week, for 5 weeks, followed by a cone down dose administered during week 6. Patients randomized to brachytherapy (Iridium 192, high-dose rate) are treated on weeks 11 and 12 and receive 2 additional courses of chemotherapy at weeks 9 and 14. Patients randomized to no brachytherapy receive additional chemotherapy courses on weeks 9 and 13. Quality of life is assessed. Patients are followed every 6 months for 2 years and then annually for 3 years years.

PROJECTED ACCRUAL: A total of 326 patients will be accrued for this study.

Conditions

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Esophageal Cancer

Keywords

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stage I esophageal cancer stage II esophageal cancer stage III esophageal cancer squamous cell carcinoma of the esophagus adenocarcinoma of the esophagus

Study Design

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Allocation Method

RANDOMIZED

Primary Study Purpose

TREATMENT

Interventions

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chemotherapy

Intervention Type DRUG

cisplatin

Intervention Type DRUG

fluorouracil

Intervention Type DRUG

brachytherapy

Intervention Type RADIATION

radiation therapy

Intervention Type RADIATION

Eligibility Criteria

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Inclusion Criteria

PATIENT CHARACTERISTICS: Age: 18 to 74 Performance status: 0-2 Hematopoietic: WBC at least 2,000/mm3 Polymorphonuclear lymphocyte count at least 1,500/mm3 Platelet count at least 80,000/mm3 Hemoglobin at least 10 g/dL Hepatic: Not specified Renal: Creatinine less than 2.8 mg/dL Cardiovascular: No angina pectoris No history of myocardial infarction No contraindication to therapy on EKG No other cardiac contraindication to chemotherapy Other: No peripheral neuropathy No second malignancy except basal cell skin cancer, carcinoma in situ of the cervix, or other carcinoma in remission for at least 2 years Not pregnant or nursing Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY: Biologic: Not specified Chemotherapy: Not specified Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: See Disease Characteristics Other: No prior laser therapy No prior electrocoagulation No prior cryotherapy No prior sclerosing injection
Minimum Eligible Age

18 Years

Maximum Eligible Age

74 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Lyon Sud

OTHER

Sponsor Role lead

Principal Investigators

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Jean-Pierre Gerard, MD

Role: STUDY_CHAIR

Centre Hospitalier Lyon Sud

Locations

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Hopital Jules Courmont - Centre Hospitalier Lyon Sud

Pierre-Bénite, , France

Site Status

Countries

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France

Other Identifiers

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CDR0000065193

Identifier Type: REGISTRY

Identifier Source: secondary_id

EU-96013

Identifier Type: -

Identifier Source: secondary_id

FRE-CURIE-HDD

Identifier Type: -

Identifier Source: org_study_id