Impact of Immunoscore Colon Test on Adjuvant Therapeutic Strategy in Non-Metastatic Colon Cancer (PROSCORE)

Unicancer

Status: Withdrawn

Conditions: Colonic Neoplasms

Treatments: Diagnostic Test: Immunoscore Colon Test

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03946033

2018-A03339-46 (Other Identifier)

UC-0110/1813

Details and patient eligibility

About

Immunoscore Colon Test (ICT) will be applied on tumor samples from curative surgery. In the Multidisciplinary Meeting (MM) evaluating the participant adjuvant strategy, a first decision will be taken, based on the participant medical record only. ICT will then be disclosed and the MM will take a second decision. The aim of the study is to observe if the ICT result modifies the treatment decision.

Full description

On previous studies, Immunoscore Colon test identified subgroups of stage II and III colon cancer patients whose Chemotherapy could be adjusted.

The study hypothesis is that Immunoscore Colon Test will modify the therapeutic decision in MM.

With Alpha and Beta at 5% and p0=10% modification rate, the participating investigators need to include 280 participants, 140 in each cohort (stage II and stage III).

Participants will have tumor samples from their curative surgery tested with Immunoscore Colon. When the patients are evaluated in MM, a first therapeutic decision will be taken before disclosing the test result. ICT result will then be communicated and a second decision will be taken.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Cytologically/histologically proven colon adenocarcinoma
• non-metastatic cancer
• Stage II or III adenocarcinoma
• Surgical resection of primitive tumor within 6 weeks of multidisciplinary meeting
• No macroscopic or microscopic proof of residual disease during surgery (R0 margins)
• Available surgical material: FFPE tumor samples
• Post-operative adjuvant chemotherapy considered during multidisciplinary meeting
• Age ≥18 years
• Eastern Cooperative Oncology Group (ECOG) performance status ≤2
• Patient having signed a written informed consent prior to any trial specific procedures
• Patient affiliated to the social security system or equivalent

Exclusion criteria

• Other invasive cancer within 5 years of the colon cancer diagnosis, except for adequately treated basal cell carcinoma or squamous cell skin carcinoma or in sity cervical carcinoma
• Patients for which adjuvant chemotherapy is contra-indicated
• Any previous systemic or loco regional anticancer therapy for the studied colon cancer (e.g. neoadjuvant therapy)
• Patient enrolled or planned to be enrolled in another clinical trial that may influence the therapeutic decision
• Any psychological, social or geographical issue that may hinder the patient's understanding of the study or the study conduct
• Person deprived of liberty or under the authority of a legal guardian
• Person unable to understand the study or to comply with the protocol procedures

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

Single arm

Other group

Description:

All participants are included in the same arm. Immunoscore Colon Test is applied on a tumor sample and the result is kept secret. In the Multidisciplinary Meeting evaluating the adjuvant therapy of the participant, a first therapeutic decision is taken, then Immunoscore result will be disclosed and the Multidisciplinary Meeting will take a second decision.

Treatment:

Diagnostic Test: Immunoscore Colon Test