Healthcare Industry News:  liver metastases 

Devices Oncology

 News Release - May 21, 2008

Sirtex Launches Global Clinical Trial Comparing the Use of SIR-Spheres(R) Microspheres Plus Chemotherapy versus Chemotherapy Alone as First Line Treatment for Metastatic Colorectal Cancer

SIRFLOX Study Marks the Largest Study of Its Kind for Colorectal liver metastases

WILMINGTON, Mass.--(HSMN NewsFeed)--Sirtex, a leading developer of targeted and innovative cancer therapies, announces an international clinical study evaluating the safety and efficacy of SIR-Spheres1 microspheres when administered with FOLFOX6 as a first line therapy in patients with non-resectable colorectal liver metastases compared to chemotherapy alone. Dr. Peter Gibbs, medical oncologist with the Royal Melbourne Hospital in Parkville, Australia, and Dr. Guy Van Hazel, medical oncologist with Mount Medical Centre in Perth, Australia, will serve as principal investigators for the trial.

Colorectal cancer is the second most common cancer in developed countries with 700,000 new cases and 400,000 deaths each year worldwide. Of that number, up to 70 percent of patients will develop liver metastases, which is the leading cause of death in patients with colorectal cancer.

The SIRFLOX study, which will take place at 25-35 sites in Australia, the United States, European Union and New Zealand, is the largest of its kind. It will involve 318 patients, with progression-free survival as the primary endpoint. The trial will be conducted in the United States under an FDA-approved protocol via an Investigational Device Exemption (IDE).

“Although there are a number of options available for treating colorectal liver metastases, in reality, only a small number of patients meet eligibility criteria,” said Dr. Samuel Putnam, medical director of U.S. operations for Sirtex. “In contrast, SIR-Spheres microspheres are indicated in patients with advanced liver tumors when other treatments can’t be used. Our goal is that by combining SIR-Spheres microspheres with FOLFOX6 much earlier in the treatment process, we will document an improvement in survival time and patient quality of life.”

Study participants must be 18 years or older and have histological or radiological evidence of liver metastases of the colon or rectum. Patients must also have a life expectancy of at least three months without active treatment. After randomization, patients will receive either systemic FOLFOX6 chemotherapy or a combination of FOLFOX6 with SIR-Spheres microspheres. In addition to progression free survival, study outcomes will be determined by evaluating tumor response rate, toxicity and safety, overall survival and quality of life.

1Sirtex Medical Inc.’s SIR-Spheres microspheres are indicated for the treatment of non-resectable metastatic colorectal cancer in combination with intra-arterial FUDR chemotherapy. Information regarding other disease states or agents in combination with this device that is presented in peer-reviewed literature is different from the approved USA labeling for SIR-Spheres.

About Selective Internal Radiation Therapy (SIRT) using SIR-Spheres microspheres

Selective Internal Radiation Therapy (SIRT) is a novel treatment for inoperable liver cancer that delivers high doses of radiation directly to the site of tumors. In a minimally-invasive treatment, millions of radioactive SIR-Spheres microspheres are infused via a catheter into the liver where they selectively target liver tumors with a dose of internal radiation up to 40 times higher than conventional radiotherapy, while sparing healthy tissue.

Clinical trials have confirmed that liver cancer patients treated with SIR-Spheres microspheres have response rates higher than with other forms of treatment, resulting in increased life expectancy, greater periods without tumor activity, and improved quality of life. SIRT has been found to shrink liver tumors more than chemotherapy alone.

SIR-Spheres microspheres are approved for use in Australia, the United States of America (FDA approval), and the European Union (CE Mark) and supplied additionally in countries such as Hong Kong, Malaysia, Singapore, Thailand, Taiwan, India, Israel and Turkey with more than 7,500 patients having been treated to date.

For more information, visit

® SIR-Spheres is a Registered Trademark of Sirtex SIR-Spheres Pty Ltd

Source: Sirtex

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