PETACC-8 miR-31-3p and miR-31-5p Ancillary Study

IntegraGen

Status and phase: Completed; Phase 3

Conditions: Colorectal Cancer

Treatments: Drug: FOLFOX; Drug: Cetuximab

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03362684

IG2017001

Details and patient eligibility

About

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.

Enrollment: 1,808 patients

Sex: All

Ages: 18 to 74 years old

Volunteers: No Healthy Volunteers

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• Patient who have withdrawn their consent for PETACC08 and/or for PETACC08 translational study

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,808 participants in 2 patient groups

FOLFOX-4 plus Cetuximab

Experimental group

Treatment:

Drug: FOLFOX

Drug: Cetuximab

FOLFOX-4

Active Comparator group

Treatment:

Drug: FOLFOX