Colon Cancer Stage IIIPhase 3iMAGINENCT04488159
Immunoscore As Decision Guidance for Adjuvant Chemotherapy in Colon Cancer
A Phase 3 study testing Capecitabine, Oxaliplatin and Fluorouracil in people with Colon Cancer Stage III, run by Johannes Laengle, MD, PhD at 1 site in Austria.
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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Colon Cancer Stage III
- What is being tested?
- Capecitabine, Oxaliplatin and Fluorouracil
- Type of treatment
- Pill or oral medicine, Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteAustria
- Study dates
- 1 Dec 2024to 1 Jun 2026
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Colon Cancer Stage III
- Being tested
- Capecitabine, Oxaliplatin, Fluorouracil, Leucovorin, Immunoscore® assay
- Keywords
- Colon cancer, Immunoscore, CAPOX, FOLFOX, Physical exercise
- Medical subject headings
- Colonic Neoplasms, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CapecitabineDrug
Tablet
OxaliplatinDrug
Infusion
FluorouracilDrug
Infusion
LeucovorinDrug
Infusion
Immunoscore® assayDevice
Whole-slide tissue analysis of CD3+ and cytotoxic CD8+ T cells in the tumor and in the invasive margin
Physical exerciseOther
Increasing stair walking exercise twice a week over 12 weeks total.
| Study group | Role | What they receive |
|---|---|---|
| Immunoscore stratification | Experimental | * 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. Receives: Drug: Capecitabine; Drug: Oxaliplatin; Drug: Fluorouracil; Drug: Leucovorin; Device: Immunoscore® assay; Other: Physical exercise |
| TNM stratification | Active comparator | * 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.) Receives: Drug: Capecitabine; Drug: Oxaliplatin; Drug: Fluorouracil; Drug: Leucovorin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 3 years
Secondary outcomes (5)
Overall survival (OS)
Impact of Immunoscore stratification on OS at 3 years (time from surgery to death due to any cause)
Measured: 3 years
Time to recurrence (TTR)
Impact of Immunoscore stratification on TTR at 3 years (time from surgery to disease recurrence)
Measured: 3 years
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).
Measured: 3 years
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.
Measured: 3 years
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).
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2020
- Study start1 Dec 2024 (estimated)
- Primary completion1 Dec 2025 (estimated)
- Study completion1 Jun 2026 (estimated)
Why it stopped: Lack of funding.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colon Cancer Stage IIIStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johannes Laengle, MD, PhD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Johannes Laengle, MD, PhD, Medical University of Vienna
- Investigators
- Jérôme Galon, PhD, Principal investigator, Laboratory of Integrative Cancer Immunology, INSERM, Cordeliers Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04488159
- Sponsor's protocol ID
- iMAGINE
- Other IDs
- 2020-000401-91
- Acronym
- iMAGINE
- Status last verified
- Sep 2024
- First submitted
- 21 Jul 2020
- Last updated
- 20 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04488159
- Acronym / sponsor ID
- iMAGINE / iMAGINE
- Conditions
- Colon Cancer Stage III
- Keywords
- Colon cancer, Immunoscore, CAPOX, FOLFOX, Physical exercise
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Lack of funding.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Johannes Laengle, MD, PhDUniversity, hospital or other
- Study start
- 1 Dec 2024 (estimated)
- Primary completion
- 1 Dec 2025 (estimated)
- Study completion
- 1 Jun 2026 (estimated)
- First posted
- 27 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Immunoscore stratification | Experimental | Drug: Capecitabine, Drug: Oxaliplatin, Drug: Fluorouracil, Drug: Leucovorin, Device: Immunoscore® assay, Other: Physical exercise* 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 stratification | Active comparator | Drug: Capecitabine, Drug: Oxaliplatin, Drug: Fluorouracil, Drug: Leucovorin* 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.) |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (14 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CapecitabineTablet | Drug | Immunoscore stratification, TNM stratification |
| OxaliplatinInfusion | Drug | Immunoscore stratification, TNM stratification |
| FluorouracilInfusion | Drug | Immunoscore stratification, TNM stratification |
| LeucovorinInfusion | Drug | Immunoscore stratification, TNM stratification |
| Immunoscore® assayWhole-slide tissue analysis of CD3+ and cytotoxic CD8+ T cells in the tumor and in the invasive margin | Device | Immunoscore stratification |
| Physical exerciseIncreasing stair walking exercise twice a week over 12 weeks total. | Other | Immunoscore stratification |
Primary outcome
Disease-free survival (DFS)
Time frame: 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)
5 secondary outcomes
Overall survival (OS)
Time frame: 3 years
Time to recurrence (TTR)
Time frame: 3 years
Treatment-related adverse events (AE)
Time frame: 3 years
Health-related quality of life (HRQOL)
Time frame: 3 years
Cost analysis
Time frame: 3 years
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jérôme Galon, PhD principal investigator
Laboratory of Integrative Cancer Immunology, INSERM, Cordeliers Research Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Capecitabine, Oxaliplatin and Fluorouracil in people with Colon Cancer Stage III, run by Johannes Laengle, MD, PhD at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 20 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease-free survival (DFS) (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Sep 2024.