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
Registration number:
|
ClinicalTrials.gov Identifier: NCT00724503 |
Ethics number:
|
MEC/07/04/048 |
This study is the first of two randomised trials that will 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 is being conducted
by Sirtex Technology Pty Ltd.
The study involves the administration of chemotherapy and implantation of SIR-Spheres,
a treatment being 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 is to find out if the combination of SIRT and chemotherapy
gives improved outcomes over chemotherapy alone for this group of patients.
Approximately 450 patients will take part in the study at institutions in New Zealand,
Australia, the United States and across the globe.
Further information available at www.sirflox.com
If you would like more information please contact:
Progress
Open
Results
120 patient safety data is now available
Centres involved
The New Zealand centres participating in this study are:
- Auckland (Prof Michael Findlay)
- Palmerston North (Dr Richard Isaacs)
- Christchurch (Dr Bridget Robinson)
- Dunedin (Dr David Perez)
- Wellington (Dr Anne O'Donnell)
