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

Conditions

Metastatic Colorectal Cancer

Keywords

Colon and rectum carcinoma, Immune response, Biomarker, Prognosis

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.

Emile JF, Julié C, Le Malicot K, Lepage C, Tabernero J, Mini E, Folprecht G, Van Laethem JL, Dimet S, Boulagnon-Rombi C, Allard MA, Penault-Llorca F, Bennouna J, Laurent-Puig P, Taieb J, PETACC8 Study Investigators, Austrian Breast and Colorectal cancer Study Group (ABCSG), Belgian Group of Digestive Oncology (BGDO), Lone Nørgård Petersen, Fédération Francophone de Cancérologie Digestive (FFCD), Fédération Nationale des Centres de Lutte Contre le Cancer (UNICANCER), Fédération Nationale des Centres de Lutte Contre le Cancer Association Européenne de Recherche en Oncologie (AERO), Arbeitsgemeinschaft Internistische Onkologie (AIO), Gruppo Italiano per lo Studio dei Carcinomi dell'Apparato Digerente (GISCAD), Gruppo Oncologico dell'Italia Meridionale (GOIM), Istituto Oncologico Romagnolo (IOR), Gruppo Cooperativo Chirurgico Italiano (GOCCI), Gruppo Oncologico Nord Ovest (GONO), Gruppo Oncologico Italiano di Ricerca Clinica (GOIRC), Gruppo Cooperativo do Cancro Digestivo da Associação Portuguesa de Investigação Oncológica (GCCD, APIO), Grupo Español para el Tratamiento de los Tumores Digestivos (TTD), John Allen Bridgewater.

2017-06-2333 citations

10.1016/j.ejca.2017.04.025

Validation of the prognostic impact of lymphocyte infiltration (LI) in patients (pts) with stage III colon cancer (CC) treated with adjuvant FOLFOX+/- cetuximab: A PETACC8 translational study.

Jean‐François Emile, Karine Le Malicot, Josep Tabernero, Enrico Mini, Gunnar Folprecht et al. (12 authors)

Journal of Clinical Oncology2016-02-013 citations

10.1200/jco.2016.34.4_suppl.553

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 74 Years

Healthy volunteers

No

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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).
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))

Outcome results