Colon Cancer Stage III
Conditions
Keywords
Colon cancer, Immunoscore, CAPOX, FOLFOX, Physical exercise
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 conventional TNM-based high- or low-risk classification.
Interventions
DRUGCapecitabine
Tablet
DRUGOxaliplatin
Infusion
DRUGFluorouracil
Infusion
DRUGLeucovorin
Infusion
DEVICEImmunoscore® assay
Whole-slide tissue analysis of CD3+ and cytotoxic CD8+ T cells in the tumor and in the invasive margin
OTHERPhysical exercise
Increasing stair walking exercise twice a week over 12 weeks total.
Sponsors
Johannes Laengle, MD, PhD
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Disease-free survival (DFS) | 3 years | Impact of Immunoscore stratification on DFS at 3 years (time from surgery to first observation of disease recurrence or death due to any cause) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall survival (OS) | 3 years | Impact of Immunoscore stratification on OS at 3 years (time from surgery to death due to any cause) |
| Time to recurrence (TTR) | 3 years | Impact of Immunoscore stratification on TTR at 3 years (time from surgery to disease recurrence) |
| Treatment-related adverse events (AE) | 3 years | Impact of Immunoscore stratification on treatment-related AEs assessed according to the latest Common Terminology Criteria of Adverse Events (CTCAE). |
| Health-related quality of life (HRQOL) | 3 years | 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. |
| Cost analysis | 3 years | 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). |
Countries
Austria
Outcome results
None listed