Oncology / Haematology

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

Trial Name: ISOFOL  PI: Dr Babak Tamjid

Who can take part:

  • Patients with histologically confirmed diagnosis of Colorectal adenocarcinoma verified via biopsy
  • Patients with availability of biopsy material, from the primary tumor or metastasis, allowing for analysis of tumor gene expression.
  • Patients with non-resectable metastatic CRC planned for first line therapy with 5-FU, Leucovorin, oxaliplatin, and bevacizumab.
  • Patients with evaluable disease with at least one measurable lesion of metastatic disease (≥10 mm in longest diameter on axial image on CT-scan or alternatively MRI with <5 mm reconstruction interval) or lymph node (≥15 mm in shortest axis when assessed by CT)

Exclusion criteria:

  • Has a known additional malignancy other than colorectal adenocarcinomas (current or within the previous five years), with the exception for curatively treated non-melanoma skin cancer or in situ carcinoma of the cervix.
  • Less than 6 months between randomization and completion of the last anti-cancer treatment (chemotherapy/ radiotherapy/immunotherapy, etc.). (NB: Rectal cancer treatment shorter than 8 weeks of chemo/radiation therapy is allowed.)
  • Confirmation of progressive disease within 6 months after completion of prior adjuvant anti-cancer treatment

For further information please contact Sally Heath – 03 9784 7290

Trial Phase

Non-drug Phase 1 Phase 2 Phase 3 Phase 4