PETACC-8 miR-31-3p and miR-31-5p Ancillary Study
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 3 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: FOLFOX-4 plus Cetuximab
|
Drug: Cetuximab
Cetuximab every 2 weeks
Drug: FOLFOX
FOLFOX-4 every 2 weeks
|
| Active Comparator: FOLFOX-4
|
Drug: FOLFOX
FOLFOX-4 every 2 weeks
|
Outcome Measures
Primary Outcome Measures
- Disease Free Survival (DFS) [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]
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) [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]
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) [From date of randomization until date of death from any cause, assessed up to 7 years]
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 [From date of randomization until date of death from any cause, assessed up to 7 years]
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) [From date of the first documented recurrence to the date of death from any cause, assessed up to 7 years]
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 [From date of the first documented recurrence to the date of death from any cause, assessed up to 7 years]
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 .
Other Outcome Measures
- miR-31-3p cut-off [From the date of randomization until 7 years, or date of death from any cause.]
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.
- miR-31-5p cut-off [From the date of randomization until 7 years, or date of death from any cause.]
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.
- Distribution of miR-31-5p expression [From the date of randomization until 7 years, or date of death from any cause.]
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.
Eligibility Criteria
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
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- IntegraGen SA
- Federation Francophone de Cancerologie Digestive
- Exystat
Investigators
- Principal Investigator: Julien Taieb, MD, PhD, Hôpital Européen Georges-Pompidou
- Principal Investigator: Pierre Laurent-Puig, MD, PhD, Hôpital Européen Georges-Pompidou
Study Documents (Full-Text)
None provided.More Information
Publications
- IG2017001