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* Immunoscore low (I-Low; I0-1): 3 months CAPOX (oxaliplatin 130 mg/m2 IV over 2 h and capecitabine 1000 mg/m2 PO twice daily (days 1-14). 21-day treatment cycle.). Concomitantly, standardised physical excise (stair walking excise twice a week for 12 weeks), which will be monitored by an electronic sports device.
* Immunoscore intermediate-high (I-IntHi; I2-3): 6 months FOLFOX (oxaliplatin 85 mg/m2 IV (on day 1) and folinic acid 200 mg/m2 IV over 2 h, followed by a bolus of fluorouracil 400 mg/m2 IV over 2-4 min, followed by fluorouracil 600 mg/m2 IV over 22 h (for 2 consecutive days). 14-day treatment cycle.)
* Immunoscore high (I high; I4): no adjuvant treatment.

* TNM-based low-risk (pT1, pT2 or pT3 and pN1): 3 months CAPOX (oxaliplatin 130 mg/m2 IV over 2 h and capecitabine 1000 mg/m2 PO twice daily (days 1-14). 21-day treatment cycle.)
* TNM-based high-risk (pT4 and/or pN2): 6 months FOLFOX (oxaliplatin 85 mg/m2 IV (on day 1) and folinic acid 200 mg/m2 IV over 2 h, followed by a bolus of fluorouracil 400 mg/m2 IV over 2-4 min, followed by fluorouracil 600 mg/m2 IV over 22 h (for 2 consecutive days). 14-day treatment cycle.)

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

Immunoscore® assay

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

Physical exercise

Johannes Laengle, MD, PhD

Michael Bergmann, MD

Michale Bergmann, MD

Jérôme Galon, PhD

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.

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

Impact of Immunoscore stratification on DFS at 3 years (time from surgery to first observation of disease recurrence or death due to any cause)

Impact of Immunoscore stratification on OS at 3 years (time from surgery to death due to any cause)

Impact of Immunoscore stratification on TTR at 3 years (time from surgery to disease recurrence)

Impact of Immunoscore stratification on treatment-related AEs assessed according to the latest Common Terminology Criteria of Adverse Events (CTCAE).

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.

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).

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Immunoscore as Decision Guidance for Adjuvant Chemotherapy in Colon Cancer	NCT04488159	Colon Cancer St...	Capecitabine Oxaliplatin Fluorouracil Leucovorin Immunoscore® as... Physical exerci...	18 Years - 100 Years	Medical University of Vienna
Immunoscore as Decision Guidance for Adjuvant Chemotherapy in Colon Cancer	NCT04488159	Colon Cancer St...	Capecitabine Oxaliplatin Fluorouracil Leucovorin Immunoscore® as... Physical exerci...	18 Years - 100 Years	Medical University of Vienna

Spots Global Cancer Trial Database for immunoscore® assay