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Surgery With or Without Combination Chemotherapy in Treating Patients With Cancer of the Esophagus Clinical Trials Information presented on Clinical Trials Search isn't designed to be a substitute for certified healthcare advice, travels to or professional assistance using a genuine medical doctor. We are not physicians. Always confer with your dr. about Surgery With or Without Combination Chemotherapy in Treating Patients With Cancer of the Esophagus conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Surgery With or Without Combination Chemotherapy in Treating Patients With Cancer of the Esophagus Clinical research trials and Surgery With or Without Combination Chemotherapy in Treating Patients With Cancer of the Esophagus medical trials happen in hundreds of places across the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually measure the effectualness of new drugs. The intention of the studies / undertakings is to solve certain human healthcare questions. Clinical trials are a popular manner for mDs, government agencies, and private sector companies to locate treatments for all forms of circumstances, such as Surgery With or Without Combination Chemotherapy in Treating Patients With Cancer of the Esophagus. Surgery With or Without Combination Chemotherapy in Treating Patients With Cancer of the Esophagus Clinical Trials and other clinical trials allow for volunteers to undergo medical treatment choices before they are available to the general public. Some times the human subjects get treatment for free of charge, and sometimes they are paid for their time. Occasionally there is a cost for a Surgery With or Without Combination Chemotherapy in Treating Patients With Cancer of the Esophagus clinical trial. Participants frequently get the best healthcare available for their Surgery With or Without Combination Chemotherapy in Treating Patients With Cancer of the Esophagus condition. Risks are a reality, nonetheless, and can include extra or frequent physician trips, medical risks (possibly life-jeopardising), and/or the treatment being ineffective. Trials are federally governed with exacting guidelines to protect clinical trials subjects.
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Home > "S" Clinical Trials Conditions > Surgery With or Without Combination Chemotherapy in Treating Patients With Cancer of the Esophagus  Surgery With or Without Combination Chemotherapy in Treating Patients With Cancer of the Esophagus
Surgery With or Without Combination Chemotherapy in Treating Patients With Cancer of the Esophagus
For Condition: stage 2 gastric cancer,Adenocarcinoma of the Esophagus,stage 1 gastric cancer,adenocarcinoma of the stomach,stage 2 esophageal cancer,stage 1 esophageal cancer
Status: Recruiting
Sponsor(s): Federation Nationale des Centres de Lutte Contre le Cancer ,
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not known whether combining chemotherapy with surgery is more effective than surgery alone. PURPOSE: Randomizedphase III trial to compare the effectiveness of surgery with or without combination chemotherapy in treating patients with cancer of the esophagus.
Details: OBJECTIVES: - Compare survival in patients with operable adenocarcinoma of the lower third of the esophagus or the cardia treated with fluorouracil/cisplatin vs. no chemotherapy prior to surgical resection. - Assess whether neoadjuvant fluorouracil/cisplatin increases tumor resectability. OUTLINE: This study is randomized for neoadjuvant chemotherapy. Patients are stratified by performance status, tumor location, and randomizing center. Patients randomized to no neoadjuvant chemotherapy undergo resection of the tumor with adequate margins and resection of regional lymph nodes (R2 with at least 8 nodal groups recommended). Patients randomized to neoadjuvant chemotherapy receive fluorouracil and cisplatin at 3-4 week intervals; fluorouracil is given by continuous intravenous infusion for 5 days and cisplatin is given on the first 2 days of fluorouracil administration. Tumor response is assessed after 2 courses; responding patients with no serious toxicity receive a third course. Surgery, as above, is initiated 4-6 weeks after the second or third course of chemotherapy. Upon recovery (within 3-6 weeks), patients who responded to neoadjuvant chemotherapy receive 3-4 additional courses of postoperative chemotherapy (maximum total of 6 courses). Patients whose best response was stable disease are assessed for postoperative radiotherapy. Patients on either arm with positive resection margins, positive lymph nodes, or equivocal complete resection are referred for postoperative radiotherapy. Further therapy for patients with incomplete resection is at the discretion of the physician. Patients are followed every 3-4 months for at least 5 years. PROJECTED ACCRUAL: A total of 250 patients will be entered.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: /75 Years
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Adenocarcinoma of the lower third of the esophagus or the cardia for which complete resection is feasible - Extension to the cardia allowed - Cancer of the cardia with extension to the esophagus or stomach allowed - No in situ cancer of the cardia - No distant metastases PATIENT CHARACTERISTICS: Age: - Not over 75 Performance status: - WHO 0 or 1 Hematopoietic: - WBC at least 4,000 - Polymorphonuclear lymphocytes greater than 2,000 - Platelets at least 100,000 Hepatic: - Not specified Renal: - Creatinine less than 1.3 mg/dL (120 micromoles/L) Cardiovascular: - No prior myocardial infarction - No other cardiac contraindication to surgery Pulmonary: - No respiratory contraindication to surgery Other: - No second malignancy except: - Basal cell carcinoma of the skin - Adequately treated in situ carcinoma of the uterine cervix PRIOR CONCURRENT THERAPY: Biologic therapy - Not specified Chemotherapy - No prior chemotherapy for tumors of the cardia Endocrine therapy - No prior radiotherapy for tumors of the cardia Radiotherapy - Not specified Surgery - Not specified
Total Enrollment:
Location and Contact Information:
Overall Study Official:
MarcYchou, Study Chair, Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle
Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle *Recruiting*
Montpellier, , 34298
France
Recruiting Marc Ychou 33-04-67-613-066
Additional Information:
Study ID Numbers: CDR0000065190; FRE-FNCLCC-94012,EU-96018
Study Start Date:
Record last reviewed: September 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002883
Other Stage 1 Gastric Cancer Studies:
1. Esophagectomy in Treating Patients With High-Grade Dysplasia of the Esophagus or Stage I, Stage II, or Stage III Esophageal Cancer
2. Surgery With or Without Chemotherapy and Radiation Therapy in Treating Patients With Cancer of the Esophagus
3. Quality-of-Life Assessment of Patients Who Have Cancer of the Esophagus
4. Celecoxib, Paclitaxel, and Carboplatin in Treating Patients With Cancer of the Esophagus
5. Surgery With or Without Radiation Therapy and Chemotherapy in Treating Patients With Esophageal Cancer
Related Studies:
Other stage 1 gastric cancer Clinical Trials
Other Clinical Trials
Other Montpellier Clinical Trials
Surgery With or Without Combination Chemotherapy in Treating Patients With Cancer of the Esophagus
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