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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A | Patients with no or low immune response (score 1 or 2) with linear quantification of CD3+ cells | ||
| Arm B | Patients with high immune response (score 3 or 4) with linear quantification of CD3+ cells |
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| Measure | Description | Time Frame |
|---|---|---|
| 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)) | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS) | Overall survival is defined as the time from randomization to death any cause or last follow-up news (censored data). | 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)) |
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Inclusion Criteria:
Exclusion Criteria:
- Patient who have withdrawn their consent for PETACC08 and/or for PETACC08 translational study
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Adult patient of both gender who have underwent surgical resection of stage III colorectal carcinoma
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| Name | Affiliation | Role |
|---|---|---|
| Emile Jean-François, Pr | Fédération Fancophone de Cancérologie Digestive | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24928083 | Background | 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. | |
| 28651158 |
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| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D012004 | Rectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
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Tissues: colorectal carcinoma and adjacent non-tumor tissues are collected in formalin fixed paraffin embedded blocks.
| 2 years |
| Result |
| Emile JF, Julie 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 Norgard Petersen; Federation Francophone de Cancerologie Digestive (FFCD); Federation Nationale des Centres de Lutte Contre le Cancer (UNICANCER); Federation Nationale des Centres de Lutte Contre le Cancer Association Europeenne 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 Associacao Portuguesa de Investigacao Oncologica (GCCD, APIO); Grupo Espanol para el Tratamiento de los Tumores Digestivos (TTD); John Allen Bridgewater. Prospective validation of a lymphocyte infiltration prognostic test in stage III colon cancer patients treated with adjuvant FOLFOX. Eur J Cancer. 2017 Sep;82:16-24. doi: 10.1016/j.ejca.2017.04.025. Epub 2017 Jun 23. |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |