NCT03422601

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 1,122 (actual)
• Sponsor: GERCOR - Multidisciplinary Oncology Cooperative Group · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Colorectal Cancer
• Stage III Colon Cancer

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Immunoscore test	To identify patients with high risk (IS 0-1) of relapse or death under oxaliplatin-based adjuvant therapy.

Timeline

• Start date: 2017-07-13
• Primary completion: 2019-06-15
• Completion: 2019-07-15
• First posted: 2018-02-05
• Last updated: 2019-02-27

Locations

1 site across 1 country: France