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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03362684
Recruitment Status : Completed
First Posted : December 5, 2017
Last Update Posted : December 5, 2017
Sponsor:
Collaborators:
Federation Francophone de Cancerologie Digestive
Exystat
Information provided by (Responsible Party):
IntegraGen SA

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.

Condition or disease Intervention/treatment Phase
Colorectal Cancer Drug: Cetuximab Drug: FOLFOX Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1808 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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
Actual Study Start Date : November 2005
Actual Primary Completion Date : November 2009
Actual Study Completion Date : June 30, 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Cetuximab

Arm Intervention/treatment
Experimental: FOLFOX-4 plus Cetuximab Drug: Cetuximab
Cetuximab every 2 weeks

Drug: FOLFOX
FOLFOX-4 every 2 weeks

Active Comparator: FOLFOX-4 Drug: FOLFOX
FOLFOX-4 every 2 weeks




Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 74 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03362684


Sponsors and Collaborators
IntegraGen SA
Federation Francophone de Cancerologie Digestive
Exystat
Investigators
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Principal Investigator: Julien Taieb, MD, PhD Hôpital Européen Georges-Pompidou
Principal Investigator: Pierre Laurent-Puig, MD, PhD Hôpital Européen Georges-Pompidou
Publications:
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Responsible Party: IntegraGen SA
ClinicalTrials.gov Identifier: NCT03362684    
Other Study ID Numbers: IG2017001
First Posted: December 5, 2017    Key Record Dates
Last Update Posted: December 5, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Cetuximab
Antineoplastic Agents, Immunological
Antineoplastic Agents