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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04488159
Other study ID # iMAGINE
Secondary ID 2020-000401-91
Status Not yet recruiting
Phase Phase 3
First received
Last updated
Start date December 1, 2024
Est. completion date June 1, 2026

Study information

Verified date March 2024
Source Medical University of Vienna
Contact Johannes Laengle, MD, PhD
Phone +43 1 40400 69260
Email johannes.laengle@meduniwien.ac.at
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 1638
Est. completion date June 1, 2026
Est. primary completion date December 1, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years to 100 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Capecitabine
Tablet
Oxaliplatin
Infusion
Fluorouracil
Infusion
Leucovorin
Infusion
Device:
Immunoscore® assay
Whole-slide tissue analysis of CD3+ and cytotoxic CD8+ T cells in the tumor and in the invasive margin
Other:
Physical exercise
Increasing stair walking exercise twice a week over 12 weeks total.

Locations

Country Name City State
Austria Medical University of Vienna Vienna

Sponsors (1)

Lead Sponsor Collaborator
Johannes Laengle, MD, PhD

Country where clinical trial is conducted

Austria, 

Outcome

Type Measure Description Time frame Safety issue
Primary Disease-free survival (DFS) Impact of Immunoscore stratification on DFS at 3 years (time from surgery to first observation of disease recurrence or death due to any cause) 3 years
Secondary Overall survival (OS) Impact of Immunoscore stratification on OS at 3 years (time from surgery to death due to any cause) 3 years
Secondary Time to recurrence (TTR) Impact of Immunoscore stratification on TTR at 3 years (time from surgery to disease recurrence) 3 years
Secondary Treatment-related adverse events (AE) Impact of Immunoscore stratification on treatment-related AEs assessed according to the latest Common Terminology Criteria of Adverse Events (CTCAE). 3 years
Secondary Health-related quality of life (HRQOL) 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. 3 years
Secondary Cost analysis 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). 3 years
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