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

Colorectal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03422601
• Other study ID #: IDEA ancillary study
• Status: Active, not recruiting
• Start date: July 13, 2017
• Est. completion date: July 15, 2019

Study information

• Verified date: February 2019
• Source: GERCOR - Multidisciplinary Oncology Cooperative Group
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1122
• Est. completion date: July 15, 2019
• Est. primary completion date: June 15, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms
• Stage III Colon Cancer

Intervention

Diagnostic Test:
• Immunoscore test
To identify patients with high risk (IS 0-1) of relapse or death under oxaliplatin-based adjuvant therapy.

Locations

Country	Name	City	State
France	Hôpital Saint Antoine	Paris

Sponsors (3)

Lead Sponsor	Collaborator
GERCOR - Multidisciplinary Oncology Cooperative Group	HalioDx, Methodology and quality of life unit in oncology, University hospital of Besancon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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

External Links

•   Abstract ASCO 2017