Trial | NCT03362684  Report issue

Title

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

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    1808
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.
Study Started
Nov 30
2005
Primary Completion
Nov 30
2009
Study Completion
Jun 30
2016
Last Update
Dec 05
2017

Drug Cetuximab

Cetuximab every 2 weeks

Drug FOLFOX [fluorouracil (efudex), leucovorin, oxaliplatin (eloxatin)]

FOLFOX-4 every 2 weeks

FOLFOX-4 plus Cetuximab Experimental

FOLFOX-4 Active Comparator

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Patient who have withdrawn their consent for PETACC08 and/or for PETACC08 translational study
No Results Posted