Surgery With or Without Combination Chemotherapy in Treating Patients With Cancer of the Esophagus
Recruitment status was Active, not recruiting
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Purpose
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: Randomized phase III trial to compare the effectiveness of surgery with or without combination chemotherapy in treating patients with cancer of the esophagus.
| Condition | Intervention | Phase |
|---|---|---|
|
Esophageal Cancer Gastric Cancer |
Drug: cisplatin Drug: fluorouracil Procedure: adjuvant therapy Procedure: conventional surgery Procedure: neoadjuvant therapy |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Primary Purpose: Treatment |
| Official Title: | A PROSPECTIVE RANDOMISED TRIAL OF INDUCTION CHEMOTHERAPY WITH 5-FU CONTINUOUS IV INFUSION AND CISPLATIN VERSUS SURGERY IN RESECTABLE ADENOCARCINOMA OF THE LOW THIRD OF THE ESOPHAGUS AND CARDIOESOPHAGEAL JUNCTION |
| Estimated Enrollment: | 250 |
| Study Start Date: | October 1996 |
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| Ages Eligible for Study: | up to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| France | |
| Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle | |
| Montpellier, France, 34298 | |
| Study Chair: | Marc Ychou, MD, PhD | Centre Val d'Aurelle - Paul Lamarque |
More Information
Additional Information:
Publications:
| ClinicalTrials.gov Identifier: | NCT00002883 History of Changes |
| Other Study ID Numbers: | CDR0000065190, FRE-FNCLCC-94012, EU-96018 |
| Study First Received: | November 1, 1999 |
| Last Updated: | February 6, 2009 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
|
stage I gastric cancer stage II gastric cancer stage I esophageal cancer |
stage II esophageal cancer adenocarcinoma of the stomach adenocarcinoma of the esophagus |
Additional relevant MeSH terms:
|
Adenocarcinoma Esophageal Diseases Esophageal Neoplasms Stomach Neoplasms Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Gastrointestinal Diseases Digestive System Diseases Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Head and Neck Neoplasms |
Stomach Diseases Cisplatin Fluorouracil Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Radiation-Sensitizing Agents Physiological Effects of Drugs Antimetabolites Molecular Mechanisms of Pharmacological Action Antimetabolites, Antineoplastic Immunosuppressive Agents Immunologic Factors |
ClinicalTrials.gov processed this record on June 17, 2013