Colorectal Cancer
Conditions
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.
Interventions
DRUGCetuximab
Cetuximab every 2 weeks
DRUGFOLFOX
FOLFOX-4 every 2 weeks
Sponsors
Federation Francophone de Cancerologie Digestive
Exystat
IntegraGen SA
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 74 Years
Healthy volunteers
No
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* Patient who have withdrawn their consent for PETACC08 and/or for PETACC08 translational study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 . |
| 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. |
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
Outcome results
None listed