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

Colorectal Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03362684
• Other study ID #: IG2017001
• Status: Completed
• Phase: Phase 3
• First received: November 24, 2017
• Last updated: December 4, 2017
• Start date: November 2005
• Est. completion date: June 30, 2016

Study information

• Verified date: December 2017
• Source: IntegraGen SA
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1808
• Est. completion date: June 30, 2016
• Est. primary completion date: November 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 74 Years

Eligibility

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• Patient who have withdrawn their consent for PETACC08 and/or for PETACC08 translational study

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

Drug:
• Cetuximab
Cetuximab every 2 weeks
• FOLFOX
FOLFOX-4 every 2 weeks

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
IntegraGen SA	Exystat, Federation Francophone de Cancerologie Digestive

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	miR-31-3p cut-off	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.	From the date of randomization until 7 years, or date of death from any cause.
Other	miR-31-5p cut-off	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.	From the date of randomization until 7 years, or date of death from any cause.
Other	Distribution of miR-31-5p expression	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.	From the date of randomization until 7 years, or date of death from any cause.
Primary	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
Primary	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	Overall Survival (OS)	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.	From date of randomization until date of death from any cause, assessed up to 7 years
Secondary	Prognostic and predictive value of miR-31-3p expression on OS	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 .	From date of randomization until date of death from any cause, assessed up to 7 years
Secondary	Survival after recurrence (SAR)	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.	From date of the first documented recurrence to the date of death from any cause, assessed up to 7 years
Secondary	Prognostic and predictive value of miR-31-3p expression on SAR	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 .	From date of the first documented recurrence to the date of death from any cause, assessed up to 7 years