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

• Conditions: Stage III Colon Cancer; Colorectal Cancer
• Interventions: Diagnostic Test: Immunoscore test

• Registration Number: NCT03422601
• Lead Sponsor: GERCOR - Multidisciplinary Oncology Cooperative Group

Brief Summary

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.

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 Timeline

• Study Start: 2017-07-13
• Study First Submitted: 2018-01-30
• Study First Submitted QC: 2018-01-30
• Study First Posted: 2018-02-05
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-26
• Last Update Posted: 2019-02-27
• Primary Completion: 2019-06-15
• Study Completion: 2019-07-15

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1122

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
6 months treatment	Immunoscore test	FOLFOX or CAPOX
3 months treatment	Immunoscore test	FOLFOX or CAPOX

Primary Outcome Measures

Name	Time	Method
disease-free survival (DFS)	3 years	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.

Trial Locations

Locations (1)

Hôpital Saint Antoine; 🇫🇷 Paris, France