Ignite Creation Date:
2024-05-05 @ 11:26 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00041262
Status:
UNKNOWN
Last Update Posted:
2013-08-12
First Post:
2002-07-08
Brief Title:
Combination Chemotherapy in Treating Patients With Esophageal Cancer
Sponsor:
Medical Research Council
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Prospective Randomized Trial Comparing Standard Chemotherapy Followed By Resection Versus Infusional Chemotherapy In Patients With Resectable Adenocarcinoma Of The Oesophagus
Status:
UNKNOWN
Status Verified Date:
2007-03
Last Known Status:
RECRUITING
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 Combining more than one drug may kill more tumor cells It is not yet known which regimen of combination chemotherapy is more effective in treating esophageal cancer
PURPOSE Randomized phase III trial to compare the effectiveness of two regimens of combination chemotherapy in treating patients who are undergoing surgery for esophageal cancer
PURPOSE Randomized phase III trial to compare the effectiveness of two regimens of combination chemotherapy in treating patients who are undergoing surgery for esophageal cancer
Detailed Description:
OBJECTIVES
Compare survival and quality of life of patients with resectable adenocarcinoma of the esophagus treated prior to surgery with standard chemotherapy comprising cisplatin and fluorouracil versus prolonged infusional chemotherapy comprising cisplatin epirubicin and fluorouracil
OUTLINE This is a randomized multicenter study Patients are randomized to one of two treatment arms
Arm I Standard chemotherapy Patients receive cisplatin IV over 4 hours on days 1-4 and fluorouracil IV continuously on days 1-4 Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity
Arm II Infusional chemotherapy Patients receive cisplatin IV over 4 hours on day 1 epirubicin IV on day 1 and fluorouracil IV continuously Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity
Patients undergo surgery 4-6 weeks after the last dose of fluorouracil in arm I or anytime after the fluorouracil infusion is completed in arm II
Quality of life is assessed at baseline immediately before starting the last course of chemotherapy immediately before surgery 6 weeks post-operatively and at 6 9 12 18 and 24 months after randomization
Patients are followed every 3 months for 1 year every 6 months for 5 years and then annually thereafter
Peer Reviewed and Funded or Endorsed by Cancer Research UK
PROJECTED ACCRUAL Approximately 1300 patients 650 per treatment arm will be accrued for this study
Compare survival and quality of life of patients with resectable adenocarcinoma of the esophagus treated prior to surgery with standard chemotherapy comprising cisplatin and fluorouracil versus prolonged infusional chemotherapy comprising cisplatin epirubicin and fluorouracil
OUTLINE This is a randomized multicenter study Patients are randomized to one of two treatment arms
Arm I Standard chemotherapy Patients receive cisplatin IV over 4 hours on days 1-4 and fluorouracil IV continuously on days 1-4 Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity
Arm II Infusional chemotherapy Patients receive cisplatin IV over 4 hours on day 1 epirubicin IV on day 1 and fluorouracil IV continuously Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity
Patients undergo surgery 4-6 weeks after the last dose of fluorouracil in arm I or anytime after the fluorouracil infusion is completed in arm II
Quality of life is assessed at baseline immediately before starting the last course of chemotherapy immediately before surgery 6 weeks post-operatively and at 6 9 12 18 and 24 months after randomization
Patients are followed every 3 months for 1 year every 6 months for 5 years and then annually thereafter
Peer Reviewed and Funded or Endorsed by Cancer Research UK
PROJECTED ACCRUAL Approximately 1300 patients 650 per treatment arm will be accrued for this study
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| EU-20204 | Registry Identifier | PDQ Physician Data Query | None |
| CDR0000069457 | REGISTRY | None | None |