Status:
WITHDRAWN
Immunoscore As Decision Guidance for Adjuvant Chemotherapy in Colon Cancer
Lead Sponsor:
Johannes Laengle, MD, PhD
Conditions:
Colon Cancer Stage III
Eligibility:
All Genders
18-100 years
Phase:
PHASE3
Brief 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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2026
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04488159
Start Date
December 1 2024
End Date
June 1 2026
Last Update
September 20 2024
Active Locations (1)
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1
Medical University of Vienna
Vienna, Vienna, Austria, 1090