search
Back to results

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

Primary Purpose

Esophageal Cancer

Status
Unknown status
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
chemotherapy
cisplatin
fluorouracil
brachytherapy
radiation therapy
Sponsored by
Centre Hospitalier Lyon Sud
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Esophageal Cancer focused on measuring stage I esophageal cancer, stage II esophageal cancer, stage III esophageal cancer, squamous cell carcinoma of the esophagus, adenocarcinoma of the esophagus

Eligibility Criteria

18 Years - 74 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

DISEASE CHARACTERISTICS: Histologically proven squamous cell carcinoma or adenocarcinoma of the esophagus No cancer of the cardia Stage T1, T2, T3, or T4 No tumor greater than 7 cm No tumor with diameter greater than 3 cm No involved nodes located more than 3 cm from tumor Supraclavicular nodal involvement eligible with cervical esophageal tumor No metastasis Patient ineligible for surgery because of one of the following: Condition that contraindicates surgery Refusal of surgery 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

Sites / Locations

  • Hopital Jules Courmont - Centre Hospitalier Lyon Sud

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 1, 1999
Last Updated
August 6, 2013
Sponsor
Centre Hospitalier Lyon Sud
search

1. Study Identification

Unique Protocol Identification Number
NCT00002884
Brief Title
Chemotherapy and Radiation Therapy in Treating Patients With Cancer of the Esophagus
Official Title
A PROSPECTIVE RANDOMISED NON SURGICAL TREATMENT OF OESOPHAGEAL CANCER WITH COMBINED CHEMOTHERAPY AND EXTERNAL BEAM IRRADIATION WITH VS WITHOUT HIGH-DOSE BRACHYTHERAPY
Study Type
Interventional

2. Study Status

Record Verification Date
May 2007
Overall Recruitment Status
Unknown status
Study Start Date
March 1996 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Centre Hospitalier Lyon Sud

4. Oversight

5. Study Description

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. 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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Esophageal Cancer
Keywords
stage I esophageal cancer, stage II esophageal cancer, stage III esophageal cancer, squamous cell carcinoma of the esophagus, adenocarcinoma of the esophagus

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Allocation
Randomized
Enrollment
326 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
chemotherapy
Intervention Type
Drug
Intervention Name(s)
cisplatin
Intervention Type
Drug
Intervention Name(s)
fluorouracil
Intervention Type
Radiation
Intervention Name(s)
brachytherapy
Intervention Type
Radiation
Intervention Name(s)
radiation therapy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
74 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically proven squamous cell carcinoma or adenocarcinoma of the esophagus No cancer of the cardia Stage T1, T2, T3, or T4 No tumor greater than 7 cm No tumor with diameter greater than 3 cm No involved nodes located more than 3 cm from tumor Supraclavicular nodal involvement eligible with cervical esophageal tumor No metastasis Patient ineligible for surgery because of one of the following: Condition that contraindicates surgery Refusal of surgery 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean-Pierre Gerard, MD
Organizational Affiliation
Centre Hospitalier Lyon Sud
Official's Role
Study Chair
Facility Information:
Facility Name
Hopital Jules Courmont - Centre Hospitalier Lyon Sud
City
Pierre Benite
ZIP/Postal Code
69495
Country
France

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs