Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002897
Status:
COMPLETED
Last Update Posted:
2013-09-20
First Post:
1999-11-01
Brief Title:
Surgery With or Without Chemotherapy in Treating Patients With Stage II or Stage III Cancer of the Esophagus
Sponsor:
European Institute of Oncology
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
RANDOMIZED STUDY OF PREOPERATIVE CHEMOTHERAPY VERSUS SURGERY ALONE IN ESOPHAGUS CANCER
Status:
COMPLETED
Status Verified Date:
2007-05
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 chemotherapy before surgery is more effective than surgery alone in treating cancer of the esophagus
PURPOSE Randomized phase III trial to compare the effectiveness of surgery with or without chemotherapy in treating patients with stage II or stage III cancer of the esophagus
PURPOSE Randomized phase III trial to compare the effectiveness of surgery with or without chemotherapy in treating patients with stage II or stage III cancer of the esophagus
Detailed Description:
OBJECTIVES I Compare resectability and survival in patients with stage IIIII esophageal cancer treated with neoadjuvant cisplatinfluorouracil vs surgery alone
OUTLINE This is a randomized study Patients are randomized to one of two groups The first group receives cisplatin and fluorouracil every 4 weeks for 3 courses followed by esophagectomy and regional lymphadenectomy The second group undergoes esophagectomy and regional lymphadenectomy alone All patients are followed for survival
PROJECTED ACCRUAL A total of 240 patients will be entered over 4 years
OUTLINE This is a randomized study Patients are randomized to one of two groups The first group receives cisplatin and fluorouracil every 4 weeks for 3 courses followed by esophagectomy and regional lymphadenectomy The second group undergoes esophagectomy and regional lymphadenectomy alone All patients are followed for survival
PROJECTED ACCRUAL A total of 240 patients will be entered over 4 years
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
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-96038 | None | None | None |
| CNR-012809 | None | None | None |