Ignite Creation Date:
2024-05-05 @ 11:56 AM
Last Modification Date:
2024-10-26 @ 9:17 AM
Study NCT ID:
NCT00188565
Status:
COMPLETED
Last Update Posted:
2010-08-13
First Post:
2005-09-12
Brief Title:
Celebrex With Preoperative Chemoradiation - Rectal Cancer
Sponsor:
University Health Network Toronto
Organization:
University Health Network Toronto
Study Overview
Official Title:
A Phase III Trial of Celecoxib With Preoperative Chemoradiation for Resectable Rectal Cancer With In Vivo Analysis of Celecoxib Effector Pathways
Status:
COMPLETED
Status Verified Date:
2010-08
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:
Colorectal carcinoma is the third most common cause of death from cancer Approximately 30 of colorectal carcinomas involve the rectum Optimizing local control in the pelvis while reducing treatment toxicity remains one of the principal goals of therapy for patients with locally advanced rectal carcinoma Treatment strategies that achieve this goal will have a significant impact on our societyC linical trials have shown that this type of cancer is less likely to come back if chemotherapy and radiotherapy are added to surgery A combination of all three types of therapy is now standard
Celecoxib Celebrex is a drug that lessens the action of an enzyme called cyclooxygenase-2 COX-2 also known as a COX-2 inhibitor It is an anti-inflammatory capsule drug that reduces irritation that is commonly used to treat arthritis It is not a chemotherapy drug Laboratory experiments have shown that such COX-2 inhibitors may increase the anti-cancer effect of radiotherapy without increasing radiation side effects This has not yet been confirmed in humansThe main purpose of this study is to confirm that celecoxib does not increase the side effects when given with radiotherapy and chemotherapy for rectal cancer We shall also be looking at how effective the combination of radiotherapy chemotherapy and celecoxib is in shrinking rectal cancer
Celecoxib Celebrex is a drug that lessens the action of an enzyme called cyclooxygenase-2 COX-2 also known as a COX-2 inhibitor It is an anti-inflammatory capsule drug that reduces irritation that is commonly used to treat arthritis It is not a chemotherapy drug Laboratory experiments have shown that such COX-2 inhibitors may increase the anti-cancer effect of radiotherapy without increasing radiation side effects This has not yet been confirmed in humansThe main purpose of this study is to confirm that celecoxib does not increase the side effects when given with radiotherapy and chemotherapy for rectal cancer We shall also be looking at how effective the combination of radiotherapy chemotherapy and celecoxib is in shrinking rectal cancer
Detailed Description:
None
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 |
|---|---|---|---|
| Ontario Cancer ResearchNetwork | None | None | None |