Ignite Creation Date:
2024-05-05 @ 12:09 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00250835
Status:
TERMINATED
Last Update Posted:
2015-09-01
First Post:
2005-11-04
Brief Title:
Combination of Oxaliplatin Capecitabine and Celecoxib With Concurrent Radiation for Rectal Cancer
Sponsor:
New Mexico Cancer Care Alliance
Organization:
New Mexico Cancer Care Alliance
Study Overview
Official Title:
A Phase II Trial Using a Combination of Oxaliplatin Capecitabine and Celecoxib With Concurrent Radiation for Patients With Newly Diagnosed Resectable Rectal Cancer
Status:
TERMINATED
Status Verified Date:
2015-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Low accrual
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
A combination of chemotherapy and radiation is often used to treat rectal cancer patients before surgery in an effort to shrink the tumor and make it easier to remove as well as to help increase the chances of sphincter-sparing surgery Many previous clinical studies have suggested that rectal cancer patients may survive longer if the surgery results in a pathological complete response - that is the absence of any tumor cells in the surgical specimen However there is still controversy over this This study attempts to start to answer this question by treating rectal cancer patients with a combination of chemotherapy drugs oxaliplatin and capecitabine a cyclooxygenase-2 COX-2 enzyme inhibitor and radiation before surgery The rates of pathologic complete response sphincter-sparing surgery and disease-free survival are some of the therapeutic endpoints that will be studied
Detailed Description:
Improved regional control as demonstrated by a lower incidence of local recurrence after concurrent chemoradiation delivered either pre-operatively or post-operatively for resectable rectal cancer is supported by clinical trial data but the impact on overall survival with either approach remains controversial An ideal regimen for preoperative chemoradiation in locally advanced rectal cancer would include agents that are both potent radio-sensitizers and effective in treating micro-metastatic disease without excessive toxicity The cyclooxygenase-2 COX-2 enzyme is over expressed in colorectal cancer but the exact role of this over expression in tumorigenesis remains an active area of research The area with the most potential in using cyclooxygenase-2 inhibitors in cancer treatment may be to use them as an adjunct to other modalities of treatment
Taking into consideration all the above a previous pilot trial of neoadjuvant therapy with combined oxaliplatin capecitabine celecoxib a COX-2 inhibitor and radiation was conducted in four patients with operable rectal cancer Promising results including pain relief and downstaging of cancer were observed
Therefore this single-arm phase II trial of preoperative concurrent chemoradiation for patients with T3-4N0-2M0 rectal cancer was initiated to assess patient outcomes and explore the relationship between COX-2 expression in surgical specimens and therapeutic endpoints
Taking into consideration all the above a previous pilot trial of neoadjuvant therapy with combined oxaliplatin capecitabine celecoxib a COX-2 inhibitor and radiation was conducted in four patients with operable rectal cancer Promising results including pain relief and downstaging of cancer were observed
Therefore this single-arm phase II trial of preoperative concurrent chemoradiation for patients with T3-4N0-2M0 rectal cancer was initiated to assess patient outcomes and explore the relationship between COX-2 expression in surgical specimens and therapeutic endpoints
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 |
|---|---|---|---|
| NCI-2011-02685 | REGISTRY | NCI CTRP | None |