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

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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

Tracking Information
First Submitted Date  ICMJE November 24, 2017
First Posted Date  ICMJE December 5, 2017
Last Update Posted Date December 5, 2017
Actual Study Start Date  ICMJE November 2005
Actual Primary Completion Date November 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 4, 2017)
  • 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 .
  • 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 .
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: December 4, 2017)
  • 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.
  • 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 .
  • 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.
  • 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 .
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: December 4, 2017)
  • 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.
  • 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.
  • 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.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE PETACC-8 miR-31-3p and miR-31-5p Ancillary Study
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Colorectal Cancer
Intervention  ICMJE
  • Drug: Cetuximab
    Cetuximab every 2 weeks
  • Drug: FOLFOX
    FOLFOX-4 every 2 weeks
Study Arms  ICMJE
  • Experimental: FOLFOX-4 plus Cetuximab
    Interventions:
    • Drug: Cetuximab
    • Drug: FOLFOX
  • Active Comparator: FOLFOX-4
    Intervention: Drug: FOLFOX
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 4, 2017)
1808
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 30, 2016
Actual Primary Completion Date November 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 74 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03362684
Other Study ID Numbers  ICMJE IG2017001
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party IntegraGen SA
Study Sponsor  ICMJE IntegraGen SA
Collaborators  ICMJE
  • Federation Francophone de Cancerologie Digestive
  • Exystat
Investigators  ICMJE
Principal Investigator: Julien Taieb, MD, PhD Hôpital Européen Georges-Pompidou
Principal Investigator: Pierre Laurent-Puig, MD, PhD Hôpital Européen Georges-Pompidou
PRS Account IntegraGen SA
Verification Date December 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP