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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Medical University of Vienna
Vienna, Vienna, Austria
Disease-free survival (DFS)
Impact of Immunoscore stratification on DFS at 3 years (time from surgery to first observation of disease recurrence or death due to any cause)
Time frame: 3 years
Overall survival (OS)
Impact of Immunoscore stratification on OS at 3 years (time from surgery to death due to any cause)
Time frame: 3 years
Time to recurrence (TTR)
Impact of Immunoscore stratification on TTR at 3 years (time from surgery to disease recurrence)
Time frame: 3 years
Treatment-related adverse events (AE)
Impact of Immunoscore stratification on treatment-related AEs assessed according to the latest Common Terminology Criteria of Adverse Events (CTCAE).
Time frame: 3 years
Health-related quality of life (HRQOL)
Impact of Immunoscore stratification on quality of life assessed by the latest version of the European Organization for Research and Treatment of Cancer (EORCT) Quality of Life Group (QLG) questionnaires C30 and CR29.
Time frame: 3 years
Cost analysis
Impact of Immunoscore stratification on treatment-related costs, assessed by cost-effectiveness analysis (CEA) according to the latest Good Research Practices for Cost-Effectiveness Analysis Alongside Clinical Trials of the International Society for Pharmacoeconomics and Outcomes Research (ISPOR).
Time frame: 3 years
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Infusion
Whole-slide tissue analysis of CD3+ and cytotoxic CD8+ T cells in the tumor and in the invasive margin
Increasing stair walking exercise twice a week over 12 weeks total.