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

NCT03362684 | Completed Phase 3

• 1 other identifier: IG2017001
• Study Type: interventional
• Target: 1,808
• Locations: 0 countries
• Sites: N/A

Brief 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

Colorectal Cancer

Outcome Measures

Primary Outcomes (2)

• Disease Free Survival (DFS)

  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 .

  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

• Prognostic and predictive value of miR-31-3p expression on Disease Free Survival (DFS)

  If patients with RAS/BRAF wild-type (WT), low miR-31-3p expression tumors treated with cetuximab plus FOLFOX-4 arm have improved DFS vs. patients treated with FOLFOX-4 alone, the predictive and prognostic value of miR-31-3p expression level on cetuximab efficacy relative to DFS in patients with RAS/BRAF WT tumors .

  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

Secondary Outcomes (4)

• Overall Survival (OS)

  From date of randomization until date of death from any cause, assessed up to 7 years

• Prognostic and predictive value of miR-31-3p expression on OS

  From date of randomization until date of death from any cause, assessed up to 7 years

• Survival after recurrence (SAR)

  From date of the first documented recurrence to the date of death from any cause, assessed up to 7 years

• Prognostic and predictive value of miR-31-3p expression on SAR

  From date of the first documented recurrence to the date of death from any cause, assessed up to 7 years

Other Outcomes (3)

• miR-31-3p cut-off

  From the date of randomization until 7 years, or date of death from any cause.

• miR-31-5p cut-off

  From the date of randomization until 7 years, or date of death from any cause.

• Distribution of miR-31-5p expression

  From the date of randomization until 7 years, or date of death from any cause.

Study Arms (2)

FOLFOX-4 plus Cetuximab

EXPERIMENTAL

Drug: Cetuximab; Drug: FOLFOX

FOLFOX-4

ACTIVE COMPARATOR

Drug: FOLFOX

Interventions

Cetuximab DRUG

Cetuximab every 2 weeks

FOLFOX-4 plus Cetuximab

FOLFOX DRUG

FOLFOX-4 every 2 weeks

FOLFOX-4; FOLFOX-4 plus Cetuximab

Eligibility Criteria

• Age: 18 Years - 74 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Patient who have withdrawn their consent for PETACC08 and/or for PETACC08 translational study

Sponsors & Collaborators

• IntegraGen SA: lead
• Federation Francophone de Cancerologie Digestive: collaborator
• Exystat: collaborator

Related Publications (1)

• 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.

  PMID: 24928083 BACKGROUND

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Cetuximab; Folfox protocol

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Julien Taieb, MD, PhD

  Hôpital Européen Georges-Pompidou

  PRINCIPAL INVESTIGATOR

• Pierre Laurent-Puig, MD, PhD

  Hôpital Européen Georges-Pompidou

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 24, 2017
• First Posted: December 5, 2017
• Study Start: November 1, 2005
• Primary Completion: November 1, 2009
• Study Completion: June 30, 2016
• Last Updated: December 5, 2017

Record last verified: 2017-12

Data Sharing

• IPD Sharing: Will not share