Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06616259
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-17
Brief Title:
First-line Treatment of MCapOX Cetuximab Vs MFOLFOX6 Cetuximab for RASBRAF Wild-type MSS Unresectable Left-Sided MCRC a Multicenter Randomized Controlled Phase III Study
Sponsor:
None
Organization:
None
Study Overview
Official Title:
First-line Treatment of MCapOX in Combination with Cetuximab Versus MFOLFOX6 in Combination with Cetuximab for RASBRAF Wild-type MSS Unresectable Left-Sided Metastatic Colorectal Cancer a Multicenter Randomized Controlled Phase III Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CAPCET-III
Brief Summary:
This multicenter randomized controlled phase III study is conducted to evaluate the efficacy and safety of first line mCapOX plus Cetuximab versus mFOLFOX6 plus Cetuximab for RASBRAF wild-type MSS Unresectable Left-Sided mCRC
Detailed Description:
Study participants who meet the enrollment criteria will be randomly assigned in a 11 ratio to either the mCapOX cetuximab or mFOLFOX6 cetuximab treatment groups and those who have achieved control of their disease Complete response CR Partial response PR Stable disease SD after a maximum of 12 cycles of first-line induction therapy in both groups will continue to receive Capecitabine or Capecitabine Cetuximab maintenance therapy until disease progression or toxicity is not tolerated or informed consent is withdrawn
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