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History of Changes for Study: NCT03362684
PETACC-8 miR-31-3p and miR-31-5p Ancillary Study
Latest version (submitted December 4, 2017) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 December 4, 2017 None (earliest Version on record)
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Study NCT03362684
Submitted Date:  December 4, 2017 (v1)

Open or close this module Study Identification
Unique Protocol ID: IG2017001
Brief Title: PETACC-8 miR-31-3p and miR-31-5p Ancillary Study
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
Secondary IDs:
Open or close this module Study Status
Record Verification: December 2017
Overall Status: Completed
Study Start: November 2005
Primary Completion: November 2009 [Actual]
Study Completion: June 30, 2016 [Actual]
First Submitted: November 24, 2017
First Submitted that
Met QC Criteria:
December 4, 2017
First Posted: December 5, 2017 [Actual]
Last Update Submitted that
Met QC Criteria:
December 4, 2017
Last Update Posted: December 5, 2017 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: IntegraGen SA
Responsible Party: Sponsor
Collaborators: Federation Francophone de Cancerologie Digestive
Exystat
Open or close this module Oversight
U.S. FDA-regulated Drug: No
U.S. FDA-regulated Device: No
Data Monitoring: No
Open or close this module Study Description
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:
Open or close this module Conditions
Conditions: Colorectal Cancer
Keywords:
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 3
Interventional Study Model: Parallel Assignment
Number of Arms: 2
Masking: None (Open Label)
Allocation: Randomized
Enrollment: 1808 [Actual]
Open or close this module Arms and Interventions
Arms Assigned Interventions
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
Open or close this module Outcome Measures
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.
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age: 74 Years
Sex: All
Gender Based:
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
Open or close this module Contacts/Locations
Study Officials: Julien Taieb, MD, PhD
Principal Investigator
Hôpital Européen Georges-Pompidou
Pierre Laurent-Puig, MD, PhD
Principal Investigator
Hôpital Européen Georges-Pompidou
Locations:
Open or close this module IPDSharing
Plan to Share IPD: No
Open or close this module References
Citations: 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. PubMed 24928083
Links:
Available IPD/Information:

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