Ignite Creation Date:
2024-05-06 @ 1:01 PM
Last Modification Date:
2024-10-26 @ 1:08 PM
Study NCT ID:
NCT03914170
Status:
COMPLETED
Last Update Posted:
2023-09-26
First Post:
2019-04-11
Brief Title:
Folfirinox Cetuximab Chemotherapy in First Line With Wild RAS and According to BRAF Status in Metastatic Colorectal Cancer
Sponsor:
Institut du Cancer de Montpellier - Val dAurelle
Organization:
Institut du Cancer de Montpellier - Val dAurelle
Study Overview
Official Title:
A Retrospective Study Assessing the Efficacy and Safety of Triplet Chemotherapy FOLFIRINOX Fluorouracil Oxaliplatin Irinotecan Plus Cetuximab ERBITUX as First Line Treatment in a RAS Ras Sarcoma Viral Oncogene Homolog KRAS NRAS Wild-type Metastatic Colorectal Cancer Population According to BRAF Murine Sarcoma Viral Oncogene Homolog B Status and Primary Tumor Location
Status:
COMPLETED
Status Verified Date:
2023-09
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:
ESTER
Brief Summary:
This retrospective study will evaluate patient outcomes after triplet chemotherapy FOLFIRINOX 5 Fluorouracil oxaliplatin irinotecan plus cetuximab 1st line treatment focusing on efficacy and safety in a RAS KRAS NRAS neuroblastoma rat sarcoma viral oncogene homolog wild-type metastatic colorectal cancer population and according to BRAF murine sarcoma viral oncogene homolog B status and primary tumor location
Detailed Description:
In Europe there are 447000 new cases of colorectal cancer each year Approximately 25 of patients present with metastases at initial diagnosis and almost 50 of patients with mCRC metastatic colorectal cancer will develop metastases
Chemotherapy represents the backbone of treatment and survival is linked with the administration of all three active cytotoxic agents 5-fluorouracilfolinate oxaliplatin and irinotecan in the first line treatment of metastatic colorectal disease
Monoclonal antibodies such as cetuximab in combination with chemotherapy are a first line treatment option in metastatic RAS rat sarcoma viral oncogene homolog wild type metastatic colorectal cancer mCRC
Phase II trials evaluating triplet chemotherapy plus cetuximab reported interesting results in terms of efficacy response rate resectability but at the price of an increased rate of toxic effects
This retrospective study will evaluate patient outcomes after triplet chemotherapy FOLFIRINOX 5 Fluorouracil oxaliplatin irinotecan plus cetuximab 1st line treatment focusing on efficacy and safety in a RAS KRAS NRAS neuroblastoma rat sarcoma viral oncogene homolog wild-type mCRC metastatic colorectal cancer population and according to BRAF murine sarcoma viral oncogene homolog B status and primary tumor location
Chemotherapy represents the backbone of treatment and survival is linked with the administration of all three active cytotoxic agents 5-fluorouracilfolinate oxaliplatin and irinotecan in the first line treatment of metastatic colorectal disease
Monoclonal antibodies such as cetuximab in combination with chemotherapy are a first line treatment option in metastatic RAS rat sarcoma viral oncogene homolog wild type metastatic colorectal cancer mCRC
Phase II trials evaluating triplet chemotherapy plus cetuximab reported interesting results in terms of efficacy response rate resectability but at the price of an increased rate of toxic effects
This retrospective study will evaluate patient outcomes after triplet chemotherapy FOLFIRINOX 5 Fluorouracil oxaliplatin irinotecan plus cetuximab 1st line treatment focusing on efficacy and safety in a RAS KRAS NRAS neuroblastoma rat sarcoma viral oncogene homolog wild-type mCRC metastatic colorectal cancer population and according to BRAF murine sarcoma viral oncogene homolog B status and primary tumor location
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?:
None
Is an FDA AA801 Violation?:
None