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Completed

NCT Number: NCT03362684

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

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.

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Key information

Conditions

Colorectal Cancer Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases

Age range

18 year–74 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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  • Patient who have withdrawn their consent for PETACC08 and/or for PETACC08 translational study

Treatment and study plan

Cetuximab

Drug

Cetuximab every 2 weeks

FOLFOX

Drug

FOLFOX-4 every 2 weeks

Primary outcomes

  1. Disease Free Survival (DFS)

    Time frame: 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

    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 .

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

    Time frame: 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

    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 .

Secondary outcomes

  1. Overall Survival (OS)

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

    Difference in OS 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.

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

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

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

  3. Survival after recurrence (SAR)

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

    Difference in Survival after Recurrence (SAR) 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.

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

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

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

Other outcomes

  1. miR-31-3p cut-off

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

    If pre-established cut-off for miR-31-3p expression does not achieve statistical significance, cut-off value of miR-31-3p expression that discriminates RAS Wild Type and BRAF Wild Type population treated with FOLFOX-4 + cetuximab in terms of DFS, OS and SAR.

  2. miR-31-5p cut-off

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

    Cut-off value for miR-31-5p expression which discriminates RAS Wild Type and BRAF Wild Type population treated with FOLFOX-4 + cetuximab in terms of DFS, OS and SAR.

  3. Distribution of miR-31-5p expression

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

    Distribution of miR-31-5p expression in the patient population and the correlation of miR-31-5p expression (quantitative) and of miR-31-5p expression level (low/high) with clinically significant co-variates and with the expression of miR-31-3p.

Sponsors and collaborators

Lead sponsor

IntegraGen SA

Industry

Collaborators

  • Exystat
  • Federation Francophone de Cancerologie Digestive

Registry information

Official study title

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

Important dates

Study start
2005
Primary completion
2009
Study completion
2016
First posted
Dec 5, 2017
Registry last updated
Dec 5, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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