Esophageal Cancer Clinical Trial
Official title:
A PROSPECTIVE RANDOMISED NON SURGICAL TREATMENT OF OESOPHAGEAL CANCER WITH COMBINED CHEMOTHERAPY AND EXTERNAL BEAM IRRADIATION WITH VS WITHOUT HIGH-DOSE BRACHYTHERAPY
Verified date | May 2007 |
Source | National Cancer Institute (NCI) |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Federal Government |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 326 |
Est. completion date | |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 74 Years |
Eligibility |
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 |
Allocation: Randomized, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
France | Hopital Jules Courmont - Centre Hospitalier Lyon Sud | Pierre Benite |
Lead Sponsor | Collaborator |
---|---|
Centre Hospitalier Lyon Sud |
France,
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