NCT04488159

Immunoscore As Decision Guidance for Adjuvant Chemotherapy in Colon Cancer

IMmunoscore Associated Decision GuIdance for AdjuvaNt Chemotherapy and Physical Exercise in Stage III Colon Cancer (iMAGINE): a Prospective, Randomized, Open-label, Multicenter, Phase III Clinical Trial

• Status: Withdrawn
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Johannes Laengle, MD, PhD · Academic / Other
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2024-12-01
• Primary completion: 2025-12-01
• Completion: 2026-06-01
• First posted: 2020-07-27
• Last updated: 2024-09-20

Locations

1 site across 1 country: Austria