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JOURNAL ONKOLOGIE – STUDIE
iMAGINE

Immunoscore as Decision Guidance for Adjuvant Chemotherapy in Colon Cancer

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NCT-Nummer:
NCT04488159

Studienbeginn:
Juli 2021

Letztes Update:
04.02.2021

Wirkstoff:
Capecitabine, Oxaliplatin, Fluorouracil, Leucovorin

Indikation (Clinical Trials):
Colonic Neoplasms

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
Phase 3

Sponsor:
Johannes Laengle, MD, PhD

Collaborator:
-

Studienleiter

Jérôme Galon, PhD
Principal Investigator
Laboratory of Integrative Cancer Immunology, INSERM, Cordeliers Research Center

Kontakt

Johannes Laengle, MD, PhD
Kontakt:
Phone: +43 1 40400 69260
E-Mail: johannes.laengle@meduniwien.ac.at
» Kontaktdaten anzeigen

Studienlocations
(1 von 1)

Medical University of Vienna
1090 Vienna
Austria» Google-Maps
Ansprechpartner:
Johannes Laengle, MD, PhD
Phone: +43 1 40400 69260
E-Mail: johannes.laengle@meduniwien.ac.at

Michale Bergmann, MD
Phone: +43 1 40400 69260
E-Mail: michael.bergmann@meduniwien.ac.at
» Ansprechpartner anzeigen

Studien-Informationen

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.

Ein-/Ausschlusskriterien

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

Studien-Rationale

Primary outcome:

1. 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)



Secondary outcome:

1. Overall survival (OS) (Time Frame - 3 years):
Impact of Immunoscore stratification on OS at 3 years (time from surgery to death due to any cause)

2. Time to recurrence (TTR) (Time Frame - 3 years):
Impact of Immunoscore stratification on TTR at 3 years (time from surgery to disease recurrence)

3. Treatment-related adverse events (AE) (Time Frame - 3 years):
Impact of Immunoscore stratification on treatment-related AEs assessed according to the latest Common Terminology Criteria of Adverse Events (CTCAE).

4. Quality of life (Time Frame - 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.

5. Cost analysis (Time Frame - 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).

Studien-Arme

  • Experimental: Immunoscore stratification
    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.
  • Active Comparator: TNM stratification
    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.)

Geprüfte Regime

  • Capecitabine:
    Tablet
  • Oxaliplatin:
    Infusion
  • Fluorouracil:
    Infusion
  • Leucovorin:
    Infusion
  • Immunoscore® assay:
    Whole-slide tissue analysis of CD3+ and cytotoxic CD8+ T cells in the tumor and in the invasive margin
  • Physical exercise:
    Increasing stair walking exercise twice a week over 12 weeks total.

Quelle: ClinicalTrials.gov


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