• Histologically confirmed stage III carcinoma of the colon • Medical need for an standard adjuvant chemotherapy • Suitable to withstand the course of an standard adjuvant chemotherapy MedDRA version: 21.0 Level: PT Classification code 10009955 Term: Colon cancer stage III System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Trade Name: active substance: Oxaliplatin
Product Name: Oxaliplatin
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: OXALIPLATIN
CAS Number: 61825-94-3
Trade Name: acti
Sponsors
Medizinische Universität Wien
Eligibility
Sex/Gender
All
Inclusion 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 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Impact of Immunoscore stratification on disease-free survival (DFS) at 3 years (time from surgery to first observation of disease recurrence or death due to any cause);Secondary Objective: • Overall survival (OS) at 3 years (time from surgery to death due to any cause) • Time to recurrence (TTR) at 3 years (time from surgery to disease recurrence) • Incidence of treatment-emergent adverse events • Quality of life • Cost analysis • Subgroup analysis (RFS, TTR, OS) between: o Immunoscore low (I-Low; I0-1) o Immunoscore intermediate-high (I-IntHi; I2-3) o Immunoscore high (I4) o Low-risk (pT1, pT2 or pT3 and pN1) o High-risk (pT4 and/or pN2) o Low physical exercise o High physical exercise ;Primary end point(s): see E.2.1;Timepoint(s) of evaluation of this end point: see E.2.1 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): see E.2.2;Timepoint(s) of evaluation of this end point: see E.2.2 | — |
Countries
Austria
Contacts
Public ContactOrganizational unit leader
Medizinische Universität Wien
Outcome results
None listed