Medical University of Vienna 1090 Vienna Austria» Google-Maps Ansprechpartner: Johannes Laengle, MD, PhD Phone: +43 1 40400 69260 E-Mail: johannes.laengle@meduniwien.ac.at
1. Disease-free survival (DFS) (Time Frame - 3 years): Impact of Immunoscore stratification on DFS at 3 years (time from surgery to first observation of disease recurrence or death due to any cause)
Secondary outcome:
1. Overall survival (OS) (Time Frame - 3 years): Impact of Immunoscore stratification on OS at 3 years (time from surgery to death due to any cause)
2. Time to recurrence (TTR) (Time Frame - 3 years): Impact of Immunoscore stratification on TTR at 3 years (time from surgery to disease recurrence)
3. Treatment-related adverse events (AE) (Time Frame - 3 years): Impact of Immunoscore stratification on treatment-related AEs assessed according to the latest Common Terminology Criteria of Adverse Events (CTCAE).
4. Health-related quality of life (HRQOL) (Time Frame - 3 years): 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.
5. Cost analysis (Time Frame - 3 years): 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).
Experimental: Immunoscore stratification 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.
Active Comparator: TNM stratification 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.)
