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

Metastatic Colorectal Cancer Clinical Trial

— CD3-OncoQuant  

Official title:

Biomarker Validation Study of Linear Quantification of CD3 Positive Cells in Localized Colorectal Carcinomas, Based on the Cohort of Patient Included in PETACC8 International Phase III Trial (NCT00265811)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02364024
• Other study ID #: PETACC8-BIO1
• Status: Completed
• Start date: November 2005
• Est. completion date: April 2017

Study information

• Verified date: July 2018
• Source: Federation Francophone de Cancerologie Digestive
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 856
• Est. completion date: April 2017
• Est. primary completion date: May 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 74 Years

Eligibility

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• Patient who have withdrawn their consent for PETACC08 and/or for PETACC08 translational study

Related Conditions & MeSH terms

• Carcinoma
• Colorectal Neoplasms
• Metastatic Colorectal Cancer

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Federation Francophone de Cancerologie Digestive

References & Publications (2)

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 S — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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
Secondary	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))	2 years