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Immunoscore as Decision Guidance for Adjuvant Chemotherapy in Colon Cancer (iMAGINE)

Primary Purpose

Colon Cancer Stage III

Status
Not yet recruiting
Phase
Phase 3
Locations
Austria
Study Type
Interventional
Intervention
Capecitabine
Oxaliplatin
Fluorouracil
Leucovorin
Immunoscore® assay
Physical exercise
Sponsored by
Johannes Laengle, MD, PhD
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colon Cancer Stage III focused on measuring Colon cancer, Immunoscore, CAPOX, FOLFOX, Physical exercise

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Medical University of Vienna

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Immunoscore stratification

TNM stratification

Arm Description

Immunoscore low (I-Low; I0-1): 3 months CAPOX (oxaliplatin 130 mg/m2 IV over 2 h and capecitabine 1000 mg/m2 PO twice daily (days 1-14). 21-day treatment cycle.). Concomitantly, standardised physical excise (stair walking excise twice a week for 12 weeks), which will be monitored by an electronic sports device. Immunoscore intermediate-high (I-IntHi; I2-3): 6 months FOLFOX (oxaliplatin 85 mg/m2 IV (on day 1) and folinic acid 200 mg/m2 IV over 2 h, followed by a bolus of fluorouracil 400 mg/m2 IV over 2-4 min, followed by fluorouracil 600 mg/m2 IV over 22 h (for 2 consecutive days). 14-day treatment cycle.) Immunoscore high (I high; I4): no adjuvant treatment.

TNM-based low-risk (pT1, pT2 or pT3 and pN1): 3 months CAPOX (oxaliplatin 130 mg/m2 IV over 2 h and capecitabine 1000 mg/m2 PO twice daily (days 1-14). 21-day treatment cycle.) TNM-based high-risk (pT4 and/or pN2): 6 months FOLFOX (oxaliplatin 85 mg/m2 IV (on day 1) and folinic acid 200 mg/m2 IV over 2 h, followed by a bolus of fluorouracil 400 mg/m2 IV over 2-4 min, followed by fluorouracil 600 mg/m2 IV over 22 h (for 2 consecutive days). 14-day treatment cycle.)

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Overall survival (OS)
Impact of Immunoscore stratification on OS at 3 years (time from surgery to death due to any cause)
Time to recurrence (TTR)
Impact of Immunoscore stratification on TTR at 3 years (time from surgery to disease recurrence)
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).
Quality of life
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
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).

Full Information

First Posted
July 21, 2020
Last Updated
March 14, 2023
Sponsor
Johannes Laengle, MD, PhD
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1. Study Identification

Unique Protocol Identification Number
NCT04488159
Brief Title
Immunoscore as Decision Guidance for Adjuvant Chemotherapy in Colon Cancer
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
December 1, 2023 (Anticipated)
Primary Completion Date
December 1, 2025 (Anticipated)
Study Completion Date
June 1, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Johannes Laengle, MD, PhD

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colon Cancer Stage III
Keywords
Colon cancer, Immunoscore, CAPOX, FOLFOX, Physical exercise

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1638 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Immunoscore stratification
Arm Type
Experimental
Arm Description
Immunoscore low (I-Low; I0-1): 3 months CAPOX (oxaliplatin 130 mg/m2 IV over 2 h and capecitabine 1000 mg/m2 PO twice daily (days 1-14). 21-day treatment cycle.). Concomitantly, standardised physical excise (stair walking excise twice a week for 12 weeks), which will be monitored by an electronic sports device. Immunoscore intermediate-high (I-IntHi; I2-3): 6 months FOLFOX (oxaliplatin 85 mg/m2 IV (on day 1) and folinic acid 200 mg/m2 IV over 2 h, followed by a bolus of fluorouracil 400 mg/m2 IV over 2-4 min, followed by fluorouracil 600 mg/m2 IV over 22 h (for 2 consecutive days). 14-day treatment cycle.) Immunoscore high (I high; I4): no adjuvant treatment.
Arm Title
TNM stratification
Arm Type
Active Comparator
Arm Description
TNM-based low-risk (pT1, pT2 or pT3 and pN1): 3 months CAPOX (oxaliplatin 130 mg/m2 IV over 2 h and capecitabine 1000 mg/m2 PO twice daily (days 1-14). 21-day treatment cycle.) TNM-based high-risk (pT4 and/or pN2): 6 months FOLFOX (oxaliplatin 85 mg/m2 IV (on day 1) and folinic acid 200 mg/m2 IV over 2 h, followed by a bolus of fluorouracil 400 mg/m2 IV over 2-4 min, followed by fluorouracil 600 mg/m2 IV over 22 h (for 2 consecutive days). 14-day treatment cycle.)
Intervention Type
Drug
Intervention Name(s)
Capecitabine
Intervention Description
Tablet
Intervention Type
Drug
Intervention Name(s)
Oxaliplatin
Intervention Description
Infusion
Intervention Type
Drug
Intervention Name(s)
Fluorouracil
Intervention Description
Infusion
Intervention Type
Drug
Intervention Name(s)
Leucovorin
Intervention Description
Infusion
Intervention Type
Device
Intervention Name(s)
Immunoscore® assay
Intervention Description
Whole-slide tissue analysis of CD3+ and cytotoxic CD8+ T cells in the tumor and in the invasive margin
Intervention Type
Other
Intervention Name(s)
Physical exercise
Intervention Description
Increasing stair walking exercise twice a week over 12 weeks total.
Primary Outcome Measure Information:
Title
Disease-free survival (DFS)
Description
Impact of Immunoscore stratification on DFS at 3 years (time from surgery to first observation of disease recurrence or death due to any cause)
Time Frame
3 years
Secondary Outcome Measure Information:
Title
Overall survival (OS)
Description
Impact of Immunoscore stratification on OS at 3 years (time from surgery to death due to any cause)
Time Frame
3 years
Title
Time to recurrence (TTR)
Description
Impact of Immunoscore stratification on TTR at 3 years (time from surgery to disease recurrence)
Time Frame
3 years
Title
Treatment-related adverse events (AE)
Description
Impact of Immunoscore stratification on treatment-related AEs assessed according to the latest Common Terminology Criteria of Adverse Events (CTCAE).
Time Frame
3 years
Title
Quality of life
Description
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.
Time Frame
3 years
Title
Cost analysis
Description
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).
Time Frame
3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Johannes Laengle, MD, PhD
Phone
+43 1 40400 69260
Email
johannes.laengle@meduniwien.ac.at
First Name & Middle Initial & Last Name or Official Title & Degree
Michael Bergmann, MD
Phone
+43 1 40400 69260
Email
michael.bergmann@meduniwien.ac.at
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jérôme Galon, PhD
Organizational Affiliation
Laboratory of Integrative Cancer Immunology, INSERM, Cordeliers Research Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical University of Vienna
City
Vienna
ZIP/Postal Code
1090
Country
Austria
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Johannes Laengle, MD, PhD
Phone
+43 1 40400 69260
Email
johannes.laengle@meduniwien.ac.at
First Name & Middle Initial & Last Name & Degree
Michale Bergmann, MD
Phone
+43 1 40400 69260
Email
michael.bergmann@meduniwien.ac.at
First Name & Middle Initial & Last Name & Degree
Johannes Laengle, MD, PhD
First Name & Middle Initial & Last Name & Degree
Michael Bergmann, MD

12. IPD Sharing Statement

Plan to Share IPD
No

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Immunoscore as Decision Guidance for Adjuvant Chemotherapy in Colon Cancer

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