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Chemotherapy and Radiation Therapy in Treating Patients With Cancer of the Esophagus Clinical Trials Facts presented on Clinical Trials Search isn't designed to be a substitute for proven healthcare advice, calls or treatment using a real mD. We aren't mDs. Always confer with your physician on Chemotherapy and Radiation Therapy in Treating Patients With Cancer of the Esophagus conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. Chemotherapy and Radiation Therapy in Treating Patients With Cancer of the Esophagus Clinical research trials and Chemotherapy and Radiation Therapy in Treating Patients With Cancer of the Esophagus healthcare trials happen in a lot of of localities across the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally measure the potency of new drugs. The aim of the studies / undertakings is to answer particular human medical questions. Clinical trials are a popular manner for doctors, government agencies, and private sector corporations to discover remedies for all kinds of circumstances, such as Chemotherapy and Radiation Therapy in Treating Patients With Cancer of the Esophagus. Chemotherapy and Radiation Therapy in Treating Patients With Cancer of the Esophagus Clinical Trials and other clinical trials allow volunteers to get healthcare treatment alternatives before they are available to the general public. Most times the participants receive treatment for without cost, and occasionally they are paid for their time. Sometimes there is a cost for a Chemotherapy and Radiation Therapy in Treating Patients With Cancer of the Esophagus clinical trial. Human subjects often receive the most effective healthcare possible for their Chemotherapy and Radiation Therapy in Treating Patients With Cancer of the Esophagus condition. Risks are a reality, nonetheless, and may include more or frequent dr. calls, healthcare hazards (perhaps life-threatening), and/or the treatment being ineffective. Trials are federally governed with rigorous guidelines to protect clinical trials subjects.
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Home > "C" Clinical Trials Conditions > Chemotherapy and Radiation Therapy in Treating Patients With Cancer of the Esophagus  Chemotherapy and Radiation Therapy in Treating Patients With Cancer of the Esophagus
Chemotherapy and Radiation Therapy in Treating Patients With Cancer of the Esophagus
For Condition: Adenocarcinoma of the Esophagus,stage 2 esophageal cancer,stage 3 esophageal cancer,squamous cell carcinoma of the esophagus,stage 1 esophageal cancer,childhood gastrointestinal cancer
Status: No longer recruiting
Sponsor(s): Hopital Jules Courmont - Centre Hospitalier Lyon Sud ,
Synopsis: 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.
Details: 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. PROTOCOL OUTLINE: This study is randomized for brachytherapy following external beam radiotherapy and current chemotherapy. Patients are stratified by randomizing center, tumor stage and platelet count. All patients receive fluorouracil by continuous intravenous infusion 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. Chemotherapy is adapted to the platelet count. Patients are followed every 6 months until 2 years past entry, then annually until 5 years past entry. PROJECTED ACCRUAL: A total of 326 patients will be accrued for this study.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: /74 Years
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Histologically proven squamous cell carcinoma or adenocarcinoma of the esophagus; No cancer of the cardia - Stage T1, T2, or T3; No T3 tumor greater than 7 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 either of the following: Condition that contraindicates surgery; Refusal of surgery - No ulceration or stenosis requiring dilatation at initiation of treatment --Prior/Concurrent Therapy-- - No prior laser therapy; No prior electrocoagulation; No prior cryotherapy; No prior sclerosing injection --Patient Characteristics-- - Age: Under 75 - 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 at selection (at least 40,000 at randomization); Hemoglobin at least 10 g/dL - Hepatic: Not specified - Renal: Creatinine less than 1.2 mg/dL (110 micromoles/L); Creatinine clearance at least 60 mL/min in patients over age 60 - 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 carcinoma of the skin; Carcinoma in situ of the uterine cervix; ORL carcinoma with remission for at least 2 years; Not pregnant or nursing; Adequate contraception required of fertile women
Total Enrollment:
Location and Contact Information:
Overall Study Official:
JeanGerard, Study Chair, Hopital Jules Courmont - Centre Hospitalier Lyon Sud
Hopital Jules Courmont - Centre Hospitalier Lyon Sud
Pierre-Benite, , 69495
France
Additional Information:
Study ID Numbers: CDR0000065193; FRE-CURIE-HDD,EU-96013
Study Start Date: March 1996
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002884
Other Squamous Cell Carcinoma Of The Esophagus Studies:
1. Flavopiridol and Paclitaxel in Treating Patients With Locally Advanced or Metastatic Esophageal Cancer That Has Not Responded to Previous Paclitaxel
2. Surgery With or Without Radiation Therapy and Chemotherapy in Treating Patients With Esophageal Cancer
3. Positron Emission Tomography in Determining Stage of Esophageal Cancer
4. Surgery With or Without Chemotherapy and Radiation Therapy in Treating Patients With Cancer of the Esophagus
5. Chemotherapy and Radiation Therapy in Treating Patients With Cancer of the Esophagus
Related Studies:
Other squamous cell carcinoma of the esophagus Clinical Trials
Other Clinical Trials
Other Pierre-Benite Clinical Trials
Chemotherapy and Radiation Therapy in Treating Patients With Cancer of the Esophagus
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