Validation Study of Linear Quantification of CD3+ Cells in Localized Colorectal Carcinomas

Completed

• Conditions: Metastatic Colorectal Cancer

• Registration Number: NCT02364024
• Lead Sponsor: Federation Francophone de Cancerologie Digestive

Brief Summary

The purpose of this study is to confirm that linear quantification of CD3+ cells is a prognostic biomarker in localized colorectal carcinomas.

Detailed Description

Adult patients of both gender who have underwent surgical resection of stage III colorectal carcinoma and randomised to receive a chemotherapy FOLFOX or FOLFOX + Cetuximab in the PETACC8 trial.

Study Timeline

• Study Start: 2005-11
• Primary Completion: 2009-05
• Study First Submitted: 2015-02-10
• Study First Submitted QC: 2015-02-10
• Study First Posted: 2015-02-16
• Study Completion: 2017-04
• Status Verified: 2018-07
• Last Update Submitted: 2018-07-04
• Last Update Posted: 2018-07-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 856

Inclusion Criteria

• Patient included in PETACC08 study
• Signed informed consent for translational study
• FFPE tumor sample available for CD3 staining

Exclusion Criteria

• Patient who have withdrawn their consent for PETACC08 and/or for PETACC08 translational study

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Time to Recurrence (TTR)	2 years	TTR is defined by the time between randomisation and the first event occured (Local or metastatic recurrence or death due to disease recurrence) whichever occured first or last follow-up ( Last news for patients without event (censored data))

Secondary Outcome Measures

Name	Time	Method
Disease-Free Survival (DFS)	2 years	DFS is defined by the time between randomisation and the first event occured (Local or metastatic recurrence or second cancer or death (all causes)) whichever occured first or last follow-up ( Last news for patients without event (censored data))
Overall Survival (OS)	until death	Overall survival is defined as the time from randomization to death any cause or last follow-up news (censored data).