Immunoscore as Decision Guidance for Adjuvant Chemotherapy in Colon Cancer

Colon Cancer Stage III Clinical Trial

— iMAGINE  

Official title:

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

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
• 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
• 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

Related Conditions & MeSH terms

• Colon Cancer Stage III
• Colonic Neoplasms

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