drugset / Trial / NCT03362684
PETACC-8 miR-31-3p and miR-31-5p Ancillary Study
Phase 3
Completed
1808 enrolled
IntegraGen SA
Exystat · collabFederation Francophone de Cancerologie Digestive · collab
RandomizedParallel-groupOpen-labelTreatment
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.
Timeline
- Start
- 2005-11
- Primary completion
- 2009-11
- Completion
- 2016-06-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cetuximab | Monoclonal antibody | — | — |