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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Colorectal Cancer, Stage III Colon Cancer

Intervention / Treatment
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* Diagnostic Test: Immunoscore test


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 3 months treatment<br>FOLFOX or CAPOX | Diagnostic Test: Immunoscore test<br>* To identify patients with high risk (IS 0-1) of relapse or death under oxaliplatin-based adjuvant therapy.<br>|
| 6 months treatment<br>FOLFOX or CAPOX | Diagnostic Test: Immunoscore test<br>* To identify patients with high risk (IS 0-1) of relapse or death under oxaliplatin-based adjuvant therapy.<br>|

What is the study measuring?
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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 |