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Surgery With or Without Combination Chemotherapy in Treating Patients With Cancer of the Esophagus Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for certified health advice, travels to or treatment by using a genuine physician. We are not physicians. Always consult your dr. on Surgery With or Without Combination Chemotherapy in Treating Patients With Cancer of the Esophagus conditions. Clinical Trials Search.org is a site committed 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 health trials occur in hundreds of cities throughout the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically assess the effectivity of new drugs. The propose of the studies / undertakings is to resolve certain human health questions. Clinical trials are a popular means for physicians, government agencies, and private sector companies to locate treatments for all sorts of conditions, including 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 permit volunteers to acquire medical treatment choices before they are available to the masses. Some times the test subjects obtain professional assistance for free, and every now and again they are compensated for their time. Sometimes there is a cost for a Surgery With or Without Combination Chemotherapy in Treating Patients With Cancer of the Esophagus clinical trial. Participants oftentimes recieve the most expert healthcare available for their Surgery With or Without Combination Chemotherapy in Treating Patients With Cancer of the Esophagus condition. Hazards are a reality, however, and can include extra or frequent physician visits, health risks (potentially life-endangering), and/or the treatment being uneffective. Trials are federally governed with rigorous 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 2 Esophageal Cancer Studies:
1. Bortezomib in Treating Patients With Unresectable or Metastatic Gastric Cancer or Gastroesophageal Junction Adenocarcinoma
2. Imatinib Mesylate in Treating Patients With Refractory Metastatic and/or Unresectable Stomach Cancer
3. Erlotinib in Treating Patients With Locally Advanced or Metastatic Stomach Cancer or Gastroesophageal Junction Cancer
4. Oxaliplatin and Fluorouracil Plus Radiation Therapy in Treating Patients With Primary Esophageal or Stomach Cancer
5. Surgery With or Without Combination Chemotherapy in Treating Patients With Cancer of the Esophagus
Related Studies:
Other stage 2 esophageal 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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