Ignite Creation Date:
2024-05-06 @ 7:46 AM
Last Modification Date:
2024-10-26 @ 11:52 AM
Study NCT ID:
NCT02605265
Status:
UNKNOWN
Last Update Posted:
2016-12-07
First Post:
2015-11-09
Brief Title:
Trial of Capecitabine With or Without Irinotecan Driven by UGT1A1
Sponsor:
Fudan University
Organization:
Fudan University
Study Overview
Official Title:
A Randomized Phase III Trial of Capecitabine With or Without Irinotecan Driven by UGT1A1 in Neoadjuvant Chemoradiation of Locally Advanced Rectal Cancer
Status:
UNKNOWN
Status Verified Date:
2016-12
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:
CinClare
Brief Summary:
The study evaluate the addition of Irinotecan in neoadjuvant chemoradiation Half of participants will receive capecitabine alone together with neoadjuvant CRT followed by a cycle of XELOX while the other will receive capecitabine and irinotecan during CRT followed by a cycle of XELIRI All participants will be scheduled to receive surgery 6-8 weeks after the completion of CRT then 5 cycles of adjuvant chemotherapy of XELOX
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