Clinical trial NCT04488159: Immunoscore As Decision Guidance for Adjuvant Chemotherapy in Colon Cancer
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
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Colon Cancer Stage III
Keywords: Colon cancer
Immunoscore
CAPOX
FOLFOX
Physical exercise
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2020-07-27
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

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

Primary outcomes:
measure: Disease-free survival (DFS)
timeFrame: 3 years
Secondary outcomes:
measure: Overall survival (OS)
timeFrame: 3 years
measure: Time to recurrence (TTR)
timeFrame: 3 years
measure: Treatment-related adverse events (AE)
timeFrame: 3 years
measure: Health-related quality of life (HRQOL)
timeFrame: 3 years
measure: Cost analysis
timeFrame: 3 years
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Medical University of Vienna
Study officials:
affiliation: Laboratory of Integrative Cancer Immunology, INSERM, Cordeliers Research Center
name: Jérôme Galon, PhD
role: PRINCIPAL_INVESTIGATOR
References: