Ignite Creation Date:
2025-12-24 @ 9:21 PM
Ignite Modification Date:
2025-12-25 @ 7:08 PM
Study NCT ID:
NCT00760604
Status:
TERMINATED
Last Update Posted:
2012-08-13
First Post:
2008-09-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Phase III Study of En Bloc Versus Non-En Bloc Esophagectomy in Esophageal Cancer
Sponsor:
Weill Medical College of Cornell University
Organization:
Study Overview
Official Title:
A Phase III Study of En Bloc Versus Non-En Bloc Esophagectomy in Patients With Locally Advanced Esophageal Cancer
Status:
TERMINATED
Status Verified Date:
2012-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Closed due to slow patient accrual.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to test 2 different methods of surgery to remove cancer in the esophagus. This research is being done to see whether removing more tissue and lymph nodes surrounding the tumor in the esophagus (known as transthoracic en bloc esophagectomy) offers better control of the cancer than removing less tissue and lymph nodes (known as non-en bloc esophagectomy).
Detailed Description:
The aim of this study is to determine the 5-year disease-free survival, overall survival, and time to progression comparing (Arm A) transthoracic en bloc esophagectomy and (Arm B) transhiatal or transthoracic non-en bloc esophagectomy. Randomization to the two surgical arms will take place after the patient has given written informed consent and eligibility has been established. Patients will be informed of their randomized arm prior to the day of surgery. Preoperative chemotherapy may be administered at the discretion of the treating physician. Adjuvant chemotherapy and/or radiotherapy will be prescribed at the discretion of the treating physician. All patients will be followed for recurrence and survival for 5 years.
Study Oversight
Has Oversight DMC:
False
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?: