Surgery With or Without Combination Chemotherapy in Treating Patients With Cancer of the Esophagus
|ClinicalTrials.gov Identifier: NCT00002883|
Recruitment Status : Unknown
Verified April 2001 by National Cancer Institute (NCI).
Recruitment status was: Active, not recruiting
First Posted : January 27, 2003
Last Update Posted : February 9, 2009
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 or disease||Intervention/treatment||Phase|
|Esophageal Cancer Gastric Cancer||Drug: cisplatin Drug: fluorouracil Procedure: adjuvant therapy Procedure: conventional surgery Procedure: neoadjuvant therapy||Phase 3|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||250 participants|
|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|
|Study Start Date :||October 1996|
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00002883
|Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle|
|Montpellier, France, 34298|
|Study Chair:||Marc Ychou, MD, PhD||Institut du Cancer de Montpellier - Val d'Aurelle|