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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.

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

Sponsor / Cooperative group:

Trial & Patient Characteristics

Cancer TypeBowel and colon
Trial TypeTreatment
PhasePhase III
Age Range18 years and older
SexBoth
Tumour Stream Insert
Cancer StageLocally Recurrent or Locally Advanced, Metastatic or Widespread
Anticipated Start Date2018-12-18
Anticipated End Date2023-01-31

Participating Hospitals

HospitalAshford Cancer Centre Research
Clinical Trial CoordinatorSue Yeend
Emailsyeend@adelaidecancercentre.com.au
Phone08 8292 2240
Principal InvestigatorDr Francis Parnis
Recruitment StatusRecruiting