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

NCT03362684 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1808

Last updated 2017-12-05

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Cetuximab

Cetuximab every 2 weeks

DRUG

FOLFOX

FOLFOX-4 every 2 weeks

Sponsors & Collaborators

  • Federation Francophone de Cancerologie Digestive

    collaborator OTHER

  • Exystat

    collaborator OTHER

  • IntegraGen SA

    lead INDUSTRY

Principal Investigators

  • Julien Taieb, MD, PhD · Hôpital Européen Georges-Pompidou

  • Pierre Laurent-Puig, MD, PhD · Hôpital Européen Georges-Pompidou

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
74 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-11-30
Primary Completion
2009-11-30
Completion
2016-06-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03362684 on ClinicalTrials.gov