Ignite Creation Date:
2024-05-05 @ 9:27 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002883
Status:
COMPLETED
Last Update Posted:
2021-02-23
First Post:
1999-11-01
Brief Title:
Surgery With or Without Combination Chemotherapy in Treating Patients With Cancer of the Esophagus
Sponsor:
UNICANCER
Organization:
UNICANCER
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2021-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
PURPOSE Randomized phase III trial to compare the effectiveness of surgery with or without combination chemotherapy in treating patients with cancer of the esophagus
Detailed Description:
OBJECTIVES
Compare survival in patients with operable adenocarcinoma of the lower third of the esophagus or the cardia treated with fluorouracilcisplatin vs no chemotherapy prior to surgical resection
Assess whether neoadjuvant fluorouracilcisplatin 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
Compare survival in patients with operable adenocarcinoma of the lower third of the esophagus or the cardia treated with fluorouracilcisplatin vs no chemotherapy prior to surgical resection
Assess whether neoadjuvant fluorouracilcisplatin 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| EU-96018 | None | None | None |
| FRE-FNCLCC-94012 | None | None | None |