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

NCT ID: NCT03362684

Last Updated: 2017-12-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

1808 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-11-30

Study Completion Date

2016-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Colorectal Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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FOLFOX-4 plus Cetuximab

Group Type EXPERIMENTAL

Cetuximab

Intervention Type DRUG

Cetuximab every 2 weeks

FOLFOX

Intervention Type DRUG

FOLFOX-4 every 2 weeks

FOLFOX-4

Group Type ACTIVE_COMPARATOR

FOLFOX

Intervention Type DRUG

FOLFOX-4 every 2 weeks

Interventions

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Cetuximab

Cetuximab every 2 weeks

Intervention Type DRUG

FOLFOX

FOLFOX-4 every 2 weeks

Intervention Type DRUG

Eligibility Criteria

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* Patient who have withdrawn their consent for PETACC08 and/or for PETACC08 translational study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

18 Years

Maximum Eligible Age

74 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Federation Francophone de Cancerologie Digestive

OTHER

Sponsor Role collaborator

Exystat

OTHER

Sponsor Role collaborator

IntegraGen SA

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Julien Taieb, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Hôpital Européen Georges-Pompidou

Pierre Laurent-Puig, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Hôpital Européen Georges-Pompidou

References

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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.

Reference Type BACKGROUND
PMID: 24928083 (View on PubMed)

Other Identifiers

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IG2017001

Identifier Type: -

Identifier Source: org_study_id