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  • MONARCC

    Acronym: 

    MONARCC

    ACTRN/NCT /ethics: 

    ACTRN12618000233224

    Scientific title: 

    MONARCC: A randomised phase II study of Panitumumab monotherapy and panitumumab plus 5 fluorouracil as first line therapy for RAS and BRAF wild type metastatic colorectal cancer.

    Summary of trial and patient characteristics

    Cancer Type Bowel and colon
    Trial Type Treatment
    Phase Phase II Tumour Stream Colorectal
    Age Range 18 years and older Cancer Stage Metastatic or Widespread
    Sex Both Anticipated Start Date 2018-03-30
    Molecular Target Anticipated End Date 2020-01-31
    Cancer Type Bowel and colon
    Trial Type Treatment
    Phase Phase II
    Age Range 18 years and older
    Sex Both
    Molecular Target
    Tumour Stream Colorectal
    Cancer Stage Metastatic or Widespread
    Anticipated Start Date 2018-03-30
    Anticipated End Date 2020-01-31

    Trial Summary

    This trial (MONARCC) seeks to determine what the best initial treatment is for a patient population with metastatic colorectal cancer that cannot withstand the expected side effects of the commonly used combination chemotherapy regimens. Who is it for? You may be eligible to join this study if you are aged 70 years or above and have a confirmed diagnosis of untreated metastatic colorectal cancer. Study details Participants in this study will be randomly (by chance) allocated to one of two groups. Participants in one group will receive low intensity targeted therapy, panitumumab, which is generally well tolerated as a single treatment without chemotherapy. Participants in the other group will receive panitumumab combined with chemotherapy (5FU), a standard treatment. All treatments are administered via the intravenous route (i.e. directly into the vein) and will be administered every 2 weeks until disease progression or unacceptable toxicity. All participants will be followed up to 18 months in order to assess treatment efficacy and safety. The hypothesis is that panitumumab will be a safe, acceptable, effective and convenient regimen to elderly patients with newly diagnosed advanced colorectal cancer.

    Lay Summary

    MONARCC: A randomised phase II study of Panitumumab monotherapy and panitumumab plus 5 fluorouracil as first line therapy for RAS and BRAF wild type metastatic colorectal cancer.

    Sponsor / Cooperative group

    AGITG

    Participating Hospitals

    Hospital Clinical Trial Coordinator Email Phone Principal Investigator Recruitment Status
    The Queen Elizabeth Hospital Pamela Cooper pamela.cooper@sa.gov.au 08 8222 6140 Professor Tim Price Recruiting
    Flinders Medical Centre Alex Scott-Hoy alex.scott-hoy@sa.gov.au 08 8204 4830 Recruiting