Prognostic Value of the Immunoscore® Colon Test for Disease Free Survival Stratification in Stage III Patients Under Oxaliplatin Treatment

Prognostic Value of the Immunoscore® Colon Test for Disease Free Survival Stratification in Stage III Patients Under Oxaliplatin Treatment: an Ancillary Study of IDEA France Study

The primary objective is to validate that the Immunoscore® test (IS0 to IS4) is able to identify patients with high risk (IS 0-1) of relapse or death whichever occurs first among Stage III patients under oxaliplatin-based adjuvant therapy.

Then the prognostic value of Immunoscore® Colon to predict disease free survival (DFS) will be assessed in Stage III patients under Oxaliplatin treatment in each arm of the IDEA trial (6- months and 3-months treatment).

Finally, the additive value of the Immunoscore® test to stratify the DFS will be evaluated among standard clinical and biological parameters and tumor features.

Study Overview

• Status: Unknown
• Conditions: Colorectal Cancer; Stage III Colon Cancer
• Intervention / Treatment: Diagnostic test: Immunoscore test

Detailed Description

Adult patients of both genders who have underwent surgical resection of stage III colon carcinoma and randomised to receive a 6-month or 3-month adjuvant therapy with modified FOLFOX 6 or CAPOX in the IDEA France trial.

• Study Type: Observational
• Enrollment (Actual): 1122

Contacts and Locations

Study Locations

• France
  • Paris, France
    • Hopital Saint Antoine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Adult patient of both genders who have underwent surgical resection of stage III colon carcinoma

Description

Inclusion Criteria:

• Patient and tumor characteristics; 3-year clinical Follow-Up
• Data regarding other markers (eg. MSI)
• FFPE blocks available, including core tumor + invasive margin regions

Exclusion Criteria:

• Bouin fixative

Sample type:

• adjacent FFPE slices (4 μm each) per case (although only one slide is required for CD3 and one for CD8, with center of tumor (CT) and the invasive margin(IM) cut from FFPE blocks no more than 4 months before the Immunoscore® testing

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
3 months treatment; FOLFOX or CAPOX	Diagnostic test: Immunoscore test; To identify patients with high risk (IS 0-1) of relapse or death under oxaliplatin-based adjuvant therapy.
6 months treatment; FOLFOX or CAPOX	Diagnostic test: Immunoscore test; To identify patients with high risk (IS 0-1) of relapse or death under oxaliplatin-based adjuvant therapy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
disease-free survival (DFS)	DFS is defined as the time from randomization to relapse or death, whichever occurred first. Secondary colon cancers are regarded as DFS events, whereas non-colon tumors are to be disregarded in the analysis. Patients with no defined events observed during the follow-up will be censored at the date of last disease evaluation which showed no evidence of relapse, or secondary primary colon cancer.	3 years

Collaborators and Investigators

• Sponsor: GERCOR - Multidisciplinary Oncology Cooperative Group
• Collaborators: HalioDx; Methodology and quality of life unit in oncology, University hospital of Besancon
• Investigators: Study Director: Thierry ANDRE, MD, Hopital Saint Antoine

Publications and helpful links

General Publications

• Pages F, Andre T, Taieb J, Vernerey D, Henriques J, Borg C, Marliot F, Ben Jannet R, Louvet C, Mineur L, Bennouna J, Desrame J, Faroux R, Kirilovsky A, Duval A, Laurent-Puig P, Svrcek M, Hermitte F, Catteau A, Galon J, Emile JF. Prognostic and predictive value of the Immunoscore in stage III colon cancer patients treated with oxaliplatin in the prospective IDEA France PRODIGE-GERCOR cohort study. Ann Oncol. 2020 Jul;31(7):921-929. doi: 10.1016/j.annonc.2020.03.310. Epub 2020 Apr 12. Erratum In: Ann Oncol. 2020 Sep;31(9):1276.

Study record dates

Study Major Dates

• Study Start (Actual): July 13, 2017
• Primary Completion (Anticipated): June 15, 2019
• Study Completion (Anticipated): July 15, 2019

Study Registration Dates

• First Submitted: January 30, 2018
• First Submitted That Met QC Criteria: January 30, 2018
• First Posted (Actual): February 5, 2018

Study Record Updates

• Last Update Posted (Actual): February 27, 2019
• Last Update Submitted That Met QC Criteria: February 26, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms; Colonic Neoplasms
• Other Study ID Numbers: IDEA ancillary study

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No