A PROSPECTIVE RANDOMISED NON SURGICAL TREATMENT OF OESOPHAGEAL CANCER WITH COMBINED CHEMOTHERAPY AND EXTERNAL BEAM IRRADIATION WITH VS WITHOUT HIGH-DOSE BRACHYTHERAPY
18 Years
74 Years
Both
Esophageal Cancer
Trial Information
A PROSPECTIVE RANDOMISED NON SURGICAL TREATMENT OF OESOPHAGEAL CANCER WITH COMBINED CHEMOTHERAPY AND EXTERNAL BEAM IRRADIATION WITH VS WITHOUT HIGH-DOSE BRACHYTHERAPY
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.
Inclusion 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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Primary Purpose: Treatment
Principal Investigator
Jean-Pierre Gerard, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Centre Hospitalier Lyon Sud
Authority:
United States: Federal Government
Study ID:
CDR0000065193
NCT ID:
NCT00002884
Start Date:
March 1996
Completion Date:
Related Keywords:
- Esophageal Cancer
- stage I esophageal cancer
- stage II esophageal cancer
- stage III esophageal cancer
- squamous cell carcinoma of the esophagus
- adenocarcinoma of the esophagus
- Esophageal Diseases
- Esophageal Neoplasms
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