Chemotherapy and Radiation Therapy in Treating Patients With Cancer of the Esophagus
Recruitment status was Active, not recruiting
|First Received Date ICMJE||November 1, 1999|
|Last Updated Date||February 6, 2009|
|Start Date ICMJE||March 1996|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE||Not Provided|
|Original Primary Outcome Measures ICMJE||Not Provided|
|Change History||Complete list of historical versions of study NCT00002884 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE||Not Provided|
|Original Secondary Outcome Measures ICMJE||Not Provided|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Chemotherapy and Radiation Therapy in Treating Patients With Cancer of the Esophagus|
|Official Title ICMJE||A PROSPECTIVE RANDOMISED NON SURGICAL TREATMENT OF OESOPHAGEAL CANCER WITH COMBINED CHEMOTHERAPY AND EXTERNAL BEAM IRRADIATION WITH VS WITHOUT HIGH-DOSE BRACHYTHERAPY|
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.
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.
|Study Type ICMJE||Interventional|
|Study Phase||Phase 3|
|Study Design ICMJE||Allocation: Randomized
Primary Purpose: Treatment
|Condition ICMJE||Esophageal Cancer|
|Study Arm (s)||Not Provided|
|Publications *||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Active, not recruiting|
|Estimated Enrollment ICMJE||326|
|Completion Date||Not Provided|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
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
|Ages||18 Years to 74 Years|
|Accepts Healthy Volunteers||No|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Location Countries ICMJE||France|
|NCT Number ICMJE||NCT00002884|
|Other Study ID Numbers ICMJE||CDR0000065193, FRE-CURIE-HDD, EU-96013|
|Has Data Monitoring Committee||Not Provided|
|Responsible Party||Not Provided|
|Study Sponsor ICMJE||Centre Hospitalier Lyon Sud|
|Collaborators ICMJE||Not Provided|
|Information Provided By||National Cancer Institute (NCI)|
|Verification Date||May 2007|
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