Clinical trial NCT03362684: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Colorectal Cancer
Lead sponsor: IntegraGen SA
Sponsor class: INDUSTRY
Collaborators: name: Federation Francophone de Cancerologie Digestive
name: Exystat
First posted: 2017-12-05
Enrollment: 1808
Sex: ALL
Minimum age (years): 18
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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* Patient who have withdrawn their consent for PETACC08 and/or for PETACC08 translational study

Primary outcomes:
measure: Disease Free Survival (DFS)
timeFrame: 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
measure: Prognostic and predictive value of miR-31-3p expression on Disease Free Survival (DFS)
timeFrame: 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 outcomes:
measure: Overall Survival (OS)
timeFrame: From date of randomization until date of death from any cause, assessed up to 7 years
measure: Prognostic and predictive value of miR-31-3p expression on OS
timeFrame: From date of randomization until date of death from any cause, assessed up to 7 years
measure: Survival after recurrence (SAR)
timeFrame: From date of the first documented recurrence to the date of death from any cause, assessed up to 7 years
measure: Prognostic and predictive value of miR-31-3p expression on SAR
timeFrame: From date of the first documented recurrence to the date of death from any cause, assessed up to 7 years
Other outcomes:
measure: miR-31-3p cut-off
timeFrame: From the date of randomization until 7 years, or date of death from any cause.
measure: miR-31-5p cut-off
timeFrame: From the date of randomization until 7 years, or date of death from any cause.
measure: Distribution of miR-31-5p expression
timeFrame: From the date of randomization until 7 years, or date of death from any cause.
Locations:
Study officials:
affiliation: Hôpital Européen Georges-Pompidou
name: Julien Taieb, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hôpital Européen Georges-Pompidou
name: Pierre Laurent-Puig, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.