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

Federation Francophone de Cancerologie Digestive856 enrolled

Overview

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

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 Type

OBSERVATIONAL

Enrollment

856

Conditions

Metastatic Colorectal Cancer

Eligibility

Sex: ALLMin age: 18 YearsMax age: 74 Years

Medical Language ↔ Plain English

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consent for translational study * FFPE tumor sample available for CD3 staining Exclusion Criteria: \- Patient who have withdrawn their consent for PETACC08 and/or for PETACC08 translational study

Outcomes

Primary Outcomes

Time to Recurrence (TTR)

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))

Time frame: 2 years

Secondary Outcomes

Overall Survival (OS)

Overall survival is defined as the time from randomization to death any cause or last follow-up news (censored data).

Time frame: until death

Disease-Free Survival (DFS)

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))

Time frame: 2 years

Data from ClinicalTrials.gov

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