Title
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
Phase
Phase 3Lead Sponsor
Medical University of ViennaStudy Type
InterventionalStatus
Not yet recruitingIndication/Condition
Colon Cancer Stage IIIIntervention/Treatment
Leucovorin Capecitabine Oxaliplatin Fluorouracil ...Study Participants
1638The 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.
Infusion
Tablet
Infusion
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.
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.)
Inclusion Criteria: 18-75 years of age All sexes Histologically confirmed stage III carcinoma of the colon Medical need for an adjuvant chemotherapy Suitable to withstand the course of an adjuvant chemotherapy Written informed consent form (ICF) for participation in the study Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 Exclusion Criteria: Neoadjuvant treatment Metastatic disease Pregnancy, breastfeeding or expectancy to conceive Disagreement of participants with reproductive potential to use contraception throughout the study period and for up to 180 days after the last dose of study therapy Uncontrolled or significant cardiovascular disease (myocardial infarction, uncontrolled angina, any history of clinically significant arrhythmias, QTc prolongation in males > 450 ms and > 470 ms in females, participants with history of myocarditis) Hepatitis B or C Human immunodeficiency virus (HIV) Immunodeficiency Allogeneic tissue or solid organ transplantation Systemic steroids or any other form of immunosuppressive therapy within 7 days prior to the first dose of study treatment Diagnosed and/or treated additional malignancy within 5 years of randomization, with the exception of curatively-treated basal cell or squamous cell carcinoma of the skin and/or curatively-resected in situ cervical and/or breast cancers Participants with serious or uncontrolled medical disorders Allergies and adverse drug reaction (history of allergy or hypersensitivity to study drug components, contraindications to any of the study drugs of the chemotherapy regimen) Other exclusion criteria: Prisoners or participants who are involuntarily incarcerated, participants who are compulsorily detained for treatment of either a psychiatric or physical (i.e. infectious disease) illness
