PETACC-8 miR-31-3p and miR-31-5p Ancillary Study
Primary Purpose
Colorectal Cancer
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Cetuximab
FOLFOX
Sponsored by
About this trial
This is an interventional treatment trial for Colorectal Cancer
Eligibility Criteria
Inclusion Criteria:
- Patient included in PETACC08 study
- Signed informed consent for translational study
- FFPE tumor sample available for miR-31-3p and miR-31-5p expression testing
Exclusion Criteria:
- Patient who have withdrawn their consent for PETACC08 and/or for PETACC08 translational study
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
FOLFOX-4 plus Cetuximab
FOLFOX-4
Arm Description
Outcomes
Primary Outcome Measures
Disease Free Survival (DFS)
Difference in Disease Free Survival (DFS) for RAS/BRAF wild-type patients whose primary tumors have low miR-31-3p expression when treated with cetuximab plus FOLFOX-4 vs. FOLFOX-4 only .
Prognostic and predictive value of miR-31-3p expression on Disease Free Survival (DFS)
If patients with RAS/BRAF wild-type (WT), low miR-31-3p expression tumors treated with cetuximab plus FOLFOX-4 arm have improved DFS vs. patients treated with FOLFOX-4 alone, the predictive and prognostic value of miR-31-3p expression level on cetuximab efficacy relative to DFS in patients with RAS/BRAF WT tumors .
Secondary Outcome Measures
Overall Survival (OS)
Difference in OS for RAS/BRAF wild-type patients whose primary tumors have low miR-31-3p expression when treated with cetuximab plus FOLFOX-4 vs. FOLFOX-4 only.
Prognostic and predictive value of miR-31-3p expression on OS
If patients with RAS/BRAF wild-type (WT), low miR-31-3p expression tumors treated with cetuximab plus FOLFOX-4 arm have improved OS vs. patients treated with FOLFOX-4 alone, the predictive and prognostic value of miR-31-3p expression level on cetuximab efficacy relative to OS in patients with RAS/BRAF WT tumors .
Survival after recurrence (SAR)
Difference in Survival after Recurrence (SAR) for RAS/BRAF wild-type patients whose primary tumors have low miR-31-3p expression when treated with cetuximab plus FOLFOX-4 vs. FOLFOX-4 only.
Prognostic and predictive value of miR-31-3p expression on SAR
If patients with RAS/BRAF wild-type (WT), low miR-31-3p expression tumors treated with cetuximab plus FOLFOX-4 arm have improved SAR vs. patients treated with FOLFOX-4 alone, the predictive and prognostic value of miR-31-3p expression level on cetuximab efficacy relative to SAR in patients with RAS/BRAF WT tumors .
Full Information
NCT ID
NCT03362684
First Posted
November 24, 2017
Last Updated
December 4, 2017
Sponsor
IntegraGen SA
Collaborators
Federation Francophone de Cancerologie Digestive, Exystat
1. Study Identification
Unique Protocol Identification Number
NCT03362684
Brief Title
PETACC-8 miR-31-3p and miR-31-5p Ancillary Study
Official Title
Ancillary Study of miR-31-3p and miR-31-5p Expression Levels in Patients Enrolled in the PETACC-8 Study, and of the Predictive Role of miR-31-3p Expression Level on Clinical Outcomes of Patients Treated With Cetuximab
Study Type
Interventional
2. Study Status
Record Verification Date
December 2017
Overall Recruitment Status
Completed
Study Start Date
November 2005 (Actual)
Primary Completion Date
November 2009 (Actual)
Study Completion Date
June 30, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
IntegraGen SA
Collaborators
Federation Francophone de Cancerologie Digestive, Exystat
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This is a prospective-retrospective study to determine if the expression of the miRNA's miR-31-3p and miR-31-5p are prognostic of patient outcomes or predictive of the benefit from anti-EGFR therapy in stage III Colon Cancer. The present study will utilize FFPE tumor samples collected from patients enrolled in the PETACC-8 study conducted by the Fédération Francophone de Cancérologie Digestive (FFCD). This phase 3 clinical trial prospectively randomized fully resected stage III colon cancer patients to receive adjuvant treatment with either FOLFOX-4 plus cetuximab or FLOFOX-4 alone.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1808 (Actual)
8. Arms, Groups, and Interventions
Arm Title
FOLFOX-4 plus Cetuximab
Arm Type
Experimental
Arm Title
FOLFOX-4
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Cetuximab
Intervention Description
Cetuximab every 2 weeks
Intervention Type
Drug
Intervention Name(s)
FOLFOX
Intervention Description
FOLFOX-4 every 2 weeks
Primary Outcome Measure Information:
Title
Disease Free Survival (DFS)
Description
Difference in Disease Free Survival (DFS) for RAS/BRAF wild-type patients whose primary tumors have low miR-31-3p expression when treated with cetuximab plus FOLFOX-4 vs. FOLFOX-4 only .
Time Frame
From date of randomization until the date of first documented any signs or symptoms cancer relapse or date of death, whichever came first, assessed up to 7 years
Title
Prognostic and predictive value of miR-31-3p expression on Disease Free Survival (DFS)
Description
If patients with RAS/BRAF wild-type (WT), low miR-31-3p expression tumors treated with cetuximab plus FOLFOX-4 arm have improved DFS vs. patients treated with FOLFOX-4 alone, the predictive and prognostic value of miR-31-3p expression level on cetuximab efficacy relative to DFS in patients with RAS/BRAF WT tumors .
Time Frame
From date of randomization until the date of first documented any signs or symptoms cancer relapse or date of death, whichever came first, assessed up to 7 years
Secondary Outcome Measure Information:
Title
Overall Survival (OS)
Description
Difference in OS for RAS/BRAF wild-type patients whose primary tumors have low miR-31-3p expression when treated with cetuximab plus FOLFOX-4 vs. FOLFOX-4 only.
Time Frame
From date of randomization until date of death from any cause, assessed up to 7 years
Title
Prognostic and predictive value of miR-31-3p expression on OS
Description
If patients with RAS/BRAF wild-type (WT), low miR-31-3p expression tumors treated with cetuximab plus FOLFOX-4 arm have improved OS vs. patients treated with FOLFOX-4 alone, the predictive and prognostic value of miR-31-3p expression level on cetuximab efficacy relative to OS in patients with RAS/BRAF WT tumors .
Time Frame
From date of randomization until date of death from any cause, assessed up to 7 years
Title
Survival after recurrence (SAR)
Description
Difference in Survival after Recurrence (SAR) for RAS/BRAF wild-type patients whose primary tumors have low miR-31-3p expression when treated with cetuximab plus FOLFOX-4 vs. FOLFOX-4 only.
Time Frame
From date of the first documented recurrence to the date of death from any cause, assessed up to 7 years
Title
Prognostic and predictive value of miR-31-3p expression on SAR
Description
If patients with RAS/BRAF wild-type (WT), low miR-31-3p expression tumors treated with cetuximab plus FOLFOX-4 arm have improved SAR vs. patients treated with FOLFOX-4 alone, the predictive and prognostic value of miR-31-3p expression level on cetuximab efficacy relative to SAR in patients with RAS/BRAF WT tumors .
Time Frame
From date of the first documented recurrence to the date of death from any cause, assessed up to 7 years
Other Pre-specified Outcome Measures:
Title
miR-31-3p cut-off
Description
If pre-established cut-off for miR-31-3p expression does not achieve statistical significance, cut-off value of miR-31-3p expression that discriminates RAS Wild Type and BRAF Wild Type population treated with FOLFOX-4 + cetuximab in terms of DFS, OS and SAR.
Time Frame
From the date of randomization until 7 years, or date of death from any cause.
Title
miR-31-5p cut-off
Description
Cut-off value for miR-31-5p expression which discriminates RAS Wild Type and BRAF Wild Type population treated with FOLFOX-4 + cetuximab in terms of DFS, OS and SAR.
Time Frame
From the date of randomization until 7 years, or date of death from any cause.
Title
Distribution of miR-31-5p expression
Description
Distribution of miR-31-5p expression in the patient population and the correlation of miR-31-5p expression (quantitative) and of miR-31-5p expression level (low/high) with clinically significant co-variates and with the expression of miR-31-3p.
Time Frame
From the date of randomization until 7 years, or date of death from any cause.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
74 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patient included in PETACC08 study
Signed informed consent for translational study
FFPE tumor sample available for miR-31-3p and miR-31-5p expression testing
Exclusion Criteria:
Patient who have withdrawn their consent for PETACC08 and/or for PETACC08 translational study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Julien Taieb, MD, PhD
Organizational Affiliation
Hôpital Européen Georges-Pompidou
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Pierre Laurent-Puig, MD, PhD
Organizational Affiliation
Hôpital Européen Georges-Pompidou
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
24928083
Citation
Taieb J, Tabernero J, Mini E, Subtil F, Folprecht G, Van Laethem JL, Thaler J, Bridgewater J, Petersen LN, Blons H, Collette L, Van Cutsem E, Rougier P, Salazar R, Bedenne L, Emile JF, Laurent-Puig P, Lepage C; PETACC-8 Study Investigators. Oxaliplatin, fluorouracil, and leucovorin with or without cetuximab in patients with resected stage III colon cancer (PETACC-8): an open-label, randomised phase 3 trial. Lancet Oncol. 2014 Jul;15(8):862-73. doi: 10.1016/S1470-2045(14)70227-X. Epub 2014 Jun 11.
Results Reference
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PETACC-8 miR-31-3p and miR-31-5p Ancillary Study
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