Ignite Creation Date:
2024-05-06 @ 7:16 PM
Last Modification Date:
2024-10-26 @ 3:03 PM
Study NCT ID:
NCT05948072
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-07-17
First Post:
2023-07-09
Brief Title:
CetuximabmFOLFOX6 VS mFOLFOX6 Alone in RASBRAF Wild Type Patients With High-Risk Resectable CRLM
Sponsor:
Fudan University
Organization:
Fudan University
Study Overview
Official Title:
Pre-and Post-operative Cetuximab Plus mFOLFOX6 Versus mFOLFOX6 Alone in RASBRAF Wild Type Patients With High-Risk Resectable Colorectal Liver Metastases
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-07
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:
For patients with initially resectable colorectal cancer liver metastases who have high-risk factors neoadjuvant therapy is currently considered a consensus approach However there is ongoing debate regarding the optimal treatment strategy Our study aims to investigate whether the addition of cetuximab to neoadjuvant chemotherapy improves outcomes compared to neoadjuvant chemotherapy alone The objective of this phase III clinical trial is to determine whether the combination of cetuximab and mFOLFOX6 chemotherapy is superior to neoadjuvant mFOLFOX6 chemotherapy alone for patients with initially resectable colorectal cancer liver metastases who have wild-type RASBRAF and high-risk factors
Detailed Description:
Primary
To determine whether the addition of cetuximab to neoadjuvant mFOLFOX6 chemotherapy results in improved event-free survival when compared with neoadjuvant mFOLFOX6 chemotherapy alone in patients with high-risk RASBRAF-wild-type resectable colorectal liver metastases
Secondary
To evaluate the overall survival of patients treated with these regimens
To evaluate the quality of life of patients treated with these regimens
To evaluate the preoperative remission rate safety surgical complications actual resection rate pathological resection status of patients treated with these regimens
To determine whether the addition of cetuximab to neoadjuvant mFOLFOX6 chemotherapy results in improved event-free survival when compared with neoadjuvant mFOLFOX6 chemotherapy alone in patients with high-risk RASBRAF-wild-type resectable colorectal liver metastases
Secondary
To evaluate the overall survival of patients treated with these regimens
To evaluate the quality of life of patients treated with these regimens
To evaluate the preoperative remission rate safety surgical complications actual resection rate pathological resection status of patients treated with these regimens
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None