Ignite Creation Date:
2024-05-05 @ 11:03 PM
Last Modification Date:
2024-10-26 @ 10:27 AM
Study NCT ID:
NCT01243372
Status:
COMPLETED
Last Update Posted:
2020-07-24
First Post:
2010-11-17
Brief Title:
Biomarkers in Predicting Response to Cetuximab in Patients With Advanced Colorectal Cancer
Sponsor:
Alliance for Clinical Trials in Oncology
Organization:
Alliance for Clinical Trials in Oncology
Study Overview
Official Title:
Evaluating BRAF Mutations as Predictors of Efficacy in Cetuximab-Treated Colorectal Cancer Patients A Retrospective Study of Tissues From CALGB SWOG
Status:
COMPLETED
Status Verified Date:
2020-07
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:
RATIONALE Studying samples of tissue in the laboratory from patients who received cetuximab may help doctors understand and predict how well patients will respond to treatment
PURPOSE This research study is studying biomarkers in predicting response to cetuximab in patients with advanced colorectal cancer
PURPOSE This research study is studying biomarkers in predicting response to cetuximab in patients with advanced colorectal cancer
Detailed Description:
OBJECTIVES
Primary
To determine among patients with advanced CRC whether the effect of treatment cetuximab vs bevacizumab on progression-free survival PFS depends on tumor BRAF V600E mutational status
Secondary
To study the relationships between tumor BRAF V600E mutational status OS and tumor response
OUTLINE This is a multicenter study
Previously collected formalin-fixed and paraffin-embedded baseline tumor samples are analyzed for BRAF V600E mutation Mutation status is correlated with clinical response and outcome data from patients enrolled on CALGB-C80405
Primary
To determine among patients with advanced CRC whether the effect of treatment cetuximab vs bevacizumab on progression-free survival PFS depends on tumor BRAF V600E mutational status
Secondary
To study the relationships between tumor BRAF V600E mutational status OS and tumor response
OUTLINE This is a multicenter study
Previously collected formalin-fixed and paraffin-embedded baseline tumor samples are analyzed for BRAF V600E mutation Mutation status is correlated with clinical response and outcome data from patients enrolled on CALGB-C80405
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 |
|---|---|---|---|
| CALGB-SWOG-150506-80405-BRAF | None | None | None |
| CDR0000688745 | REGISTRY | NCI Physician Data Query | None |