Immunoscore as Decision Guidance for Adjuvant Chemotherapy in Colon Cancer

• Status: Not yet recruiting
• Trial end date: 2024-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Johannes Laengle, MD, PhD
• Treatments: Capecitabine; Fluorouracil; Leucovorin; Oxaliplatin

Criteria

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