SIRFLOX

Full title: A randomised comparative study of Folfox6m plus SIR-Spheres versus Folfox6m alone as first line treatment in patients with non-resectable liver metastases from primary colorectal carcinoma
Cancer type: Metastatic Colorectal
Status: Closed
Brief description:

 

This study was the first of two randomised trials to evaluate the addition of Selective Internal Radiation Therapy (SIRT) to a regimen of FOLFOX chemotherapy for patients with liver metastases from the colorectum. The study was conducted by Sirtex Technology Pty Ltd.

The study involved the administration of chemotherapy and implantation of SIR-Spheres, a treatment developed for colorectal cancer that has spread to the liver. SIRT is a form of treatment that has been designed to selectively deliver radiation to the cancer within the liver. SIRT involves injecting very small radioactive particles (SIR-Spheres microspheres) into the blood stream of the liver. The administration of SIR-Spheres microspheres is a form of radiotherapy and is designed to destroy cancer in the liver. This form of treatment has been used in a number of clinical trials and has been approved for use in the treatment of liver cancer in Australia and other countries.

The main purpose of this study was to find out if the combination of SIRT and chemotherapy gives improved outcomes over chemotherapy alone for this group of patients.

530 patients took part in the study at institutions in New Zealand, Australia, the United States and across the globe.

Further information available at www.sirflox.com

Sites: ·        Auckland

·        Wellington

·        Palmerston North

·        Christchurch

·        Dunedin

Lead Investigator: Professor Michael Findlay
Contact: Lindsey Wylde (l.wylde@auckland.ac.nz)
Sponsor: Sirtex Medical
Funder: Sirtex Medical
Trial Registry reference: NCT00724503 (click for more details)
Ethics number: MEC/07/04/048
Publications: G. van Hazel, V. Heinemann, N. Sharma, M. Findlay et. al. SIRFLOX: Randomised phase III trial comparing first-line mFOLFOX6 (plus or minus bevacizumab) versus mFOLFOX6 (plus or minus bevacizumab) plus selective internal radiation therapy in patients with metastatic colorectal cancer. Journal of Clinical Oncology. Published online before print February 22, 2016 doi: 10.1200/JCO.2015.66.1181.