Clinical trial · Interventional

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

NCT03362684CI-TRIAL-00030674completedPhase 3ClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

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.

Conditions

Conditions (1)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Colorectal Cancer	Malignant Colorectal Neoplasm	CURATED_BROADER	0.80

Interventions

Interventions (2)

Intervention	Type	Mapped drug	Match
Cetuximab	Drug	Cetuximab	ALIAS
FOLFOX	Drug	FOLFOX Regimen	ALIAS

Design

Arms and outcomes

Arms (2)

type
EXPERIMENTAL
label
FOLFOX-4 plus Cetuximab
interventionNames
1. Drug: Cetuximab
2. Drug: FOLFOX
type
ACTIVE_COMPARATOR
label
FOLFOX-4
interventionNames
1. Drug: FOLFOX

Primary outcomes (2)

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
description
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 .

Eligibility

Eligibility (as posted)

Sex: All
Minimum age: 18 Years
Maximum age: 74 Years

Show eligibility criteria text

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* Patient who have withdrawn their consent for PETACC08 and/or for PETACC08 translational study

References

Publications (1)

BACKGROUNDTaieb 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. PMID 24928083