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Immunoscore As Decision Guidance for Adjuvant Chemotherapy in Colon Cancer

NCT04488159 · Status: WITHDRAWN · Phase: PHASE3 · Type: INTERVENTIONAL

Last updated 2024-09-20

No results posted yet for this study

Summary

The overall aim of this study is to prospectively validate the superiority of the Immunoscore as a decision guidance for adjuvant chemotherapy in stage III colon cancer patients, in comparison to the conventional TNM-based high- or low-risk classification.

Conditions

  • Colon Cancer Stage III

Interventions

DRUG

Capecitabine

Tablet

DRUG

Oxaliplatin

Infusion

DRUG

Fluorouracil

Infusion

DRUG

Leucovorin

Infusion

DEVICE

Immunoscore® assay

Whole-slide tissue analysis of CD3+ and cytotoxic CD8+ T cells in the tumor and in the invasive margin

OTHER

Physical exercise

Increasing stair walking exercise twice a week over 12 weeks total.

Sponsors & Collaborators

  • Johannes Laengle, MD, PhD

    lead OTHER

Principal Investigators

  • Jérôme Galon, PhD · Laboratory of Integrative Cancer Immunology, INSERM, Cordeliers Research Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-12-01
Primary Completion
2025-12-01
Completion
2026-06-01

Countries

  • Austria

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04488159 on ClinicalTrials.gov