SirtexMedical has completed patient recruitment for its SIRFLOX study, designed to assess SIR-Spheres microspheres as first-line treatment for colorectal liver metastases.
The world's largest interventional oncology study has enrolled over 500 patients with inoperable liver metastases from primary colorectal cancer.
Sirtex Medical president Mike Mangano said that the company was committed to large, randomised controlled trials to confirm the results from various, smaller, peer-reviewed studies that have established the effectiveness of SIR-Spheres microspheres.
"We anticipate that the data from the SIRFLOX study will provide sufficient proof to the oncology community that combining chemotherapy and internal radiation therapy earlier in the treatment algorithm will benefit patients," Mangano added.
The study will assess the effectiveness of first-line treatment strategy of standard-of-care chemotherapy along with SIR-Spheres microspheres against chemotherapy alone in delaying cancer progression in patients with inoperable liver metastases from primary colorectal cancer.
The company expects the primary results of the study to be released in late 2014.
SIRFLOX investigator and University of Maryland School of Medicine vascular and interventional radiology division interim director said, "We are excited to be the top enrolling US site in this landmark study and look forward to seeing the results, which we believe will help further guide the oncology community in best practice treatment for liver tumours from metastatic colorectal disease."
The patients with metastatic colorectal cancer showed high response rates when treated with Selective Internal Radiation Therapy (SIRT) using SIR-Spheres microspheres compared to other treatment forms in various clinical studies, the company claimed.
SIRT, also referred to as radioembolisation, delivers radiation doses to the tumor site directly in a minimally invasive treatment through a catheter.