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  • ISOFOL

    Acronym: 

    ISOFOL

    ACTRN/NCT /ethics: 

    NCT03750786

    Scientific title: 

    A Randomized, Multicenter, Parallel-group, Phase III Study to Compare the Efficacy of Arfolitixorin Versus Leucovorin in Combination With 5 Fluorouracil, Oxaliplatin, and Bevacizumab in Patients With Advanced Colorectal Cancer

    Summary of trial and patient characteristics

    Cancer Type Bowel and colon
    Trial Type Treatment
    Phase Phase III Tumour Stream Colorectal
    Age Range 18 years and older Cancer Stage Metastatic or Widespread, Locally Recurrent or Locally Advanced
    Sex Both Anticipated Start Date 2018-12-18
    Molecular Target Anticipated End Date 2023-01-31
    Cancer Type Bowel and colon
    Trial Type Treatment
    Phase Phase III
    Age Range 18 years and older
    Sex Both
    Molecular Target
    Tumour Stream Colorectal
    Cancer Stage Metastatic or Widespread, Locally Recurrent or Locally Advanced
    Anticipated Start Date 2018-12-18
    Anticipated End Date 2023-01-31

    Trial Summary

    This is a multicenter, randomized, parallel-group, Phase III study in at least 440 patients with advanced colorectal cancer to compare the efficacy of treatment with arfolitixorin versus Leucovorin in combination with 5-fluorouracil, oxaliplatin, and bevacizumab according to modified FOLFOX-6 until PD according to RECIST 1.1 criteria.

    Lay Summary

    A Randomized, Multicenter, Parallel-group, Phase III Study to Compare the Efficacy of Arfolitixorin Versus Leucovorin in Combination With 5 Fluorouracil, Oxaliplatin, and Bevacizumab in Patients With Advanced Colorectal Cancer

    Sponsor / Cooperative group

    Participating Hospitals

    Hospital Clinical Trial Coordinator Email Phone Principal Investigator Recruitment Status
    Ashford Cancer Centre Research Sue Yeend syeend@adelaidecancercentre.com.au 08 8292 2240 Dr Francis Parnis Not Yet Recruiting