Service 1998-2003 from the Hepatitis C Support Project. Hepatitis C Support Project (HCSP) since 1998. She is a member of the HCSP advisory board. Writes for various HCSP publications. For ethical reasons, the trial included a cross-over design for patients in the control arm following failure of chemotherapy alone. The study is identical in design except that the primary endpoint is Overall Survival. The primary endpoint of the study is Progression Free Survival. The SIRFLOX study, with a primary endpoint of Progression Free Survival, is a prospective randomized study looking at SIR-Spheres microspheres in combination with chemotherapy for first line treatment of patients with unresectable liver metastases from colorectal cancer. SIRFLOX is the first prospective randomized study looking at SIR-Spheres microspheres in combination with standard therapy for first line treatment, FOLFOX6 with or without bevacizumab, in patients with unresectable liver metastases from colorectal cancer. The aim of SIRFLOX is to determine if SIR-Spheres microspheres in combination with FOLFOX6 with or without bevacizumab can be considered a valid first line option for patients with liver-limited metastatic colorectal cancer. To date, 180 patients have enrolled with enrollment of 450 patients anticipated complete by the end of 2011. An independent data safety monitoring committee (IDSMC) recently finalized a safety analysis on the first 80 patients.
Lack of evidence of their safety. Found the study has no major safety issues that would preclude continuing as scheduled. The hepatitis C virus is a major source of liver disease that affects millions worldwide. Symptoms of infection can be treated medically, and the proportion of patients can clear the virus with a long program of antiviral drugs. The World Health Organization (WHO) states that 15 to 45 percent of people with acute hepatitis C spontaneously clear the virus within 6 months. After the exposure (especially if the blood exposure involved another person known to have the hepatitis C virus), it is recommended that testing for the hepatitis C antibody be performed at 4 to 6 months after the exposure OR that testing for the hepatitis C virus itself (a test often called an HCV PCR or hepatitis C viral load test) be performed 4 to 6 weeks after the potential exposure.
The HCCAP HCV Testing Sites map lists only facilities offering free or low cost hepatitis C screening services for those with limited resources due to lack of health insurance, lack of coverage for such testing, and/or limited financial resources. HCC due to these infections were estimated for 11 WHO-based regions. Surgery centre administrator Betty McCabe says the exposure was due to “deficiencies in infection control” involving the cleaning of instruments and injection of medications. Havrix is indicated for active immunisation against hepatitis A virus (HAV) infection in subjects at risk of exposure to HAV. Inactivated hepatitis A virus produced in MRC-5 cells. Whenever someone comes to a hospital infected with a virus, there's a chance that virus can spread to other patients. “These two independent studies provide further evidence that SIR-Spheres microspheres can improve clinical outcomes in a patient population with limited treatment options,” said Michael Mangano, President, Sirtex Medical Inc. “We are excited that the SIRFLOX trial is well underway in the United States. It is anticipated that data on over 800 patients from the two trials can be combined to determine an Overall Survival endpoint across both studies. Median survival increased from 7.3 months in the chemotherapy control arm to 10 months in the SIR-Spheres microspheres plus chemotherapy arm.
The median overall survival for the trial was 12.6 months. The results revealed an overall response rate of 24 percent, which met the trial’s pre-determined criteria for significance, plus stable disease reported in a further 24 percent of patients. I always knew that the cure was a transplant as it is an incurable disease but it depends on how the disease progresses. She has since been placed on the waiting list for a liver transplant. As a nurse, I've seen the wreckage of liver disease and I revere the strength it takes to live with adversity. We believe that this study, along with FOXFIRE, will confirm that SIR-Spheres microspheres should be added to modern first-line chemotherapy for patients with metastatic colorectal cancer, to extend survival, in line with the clinical benefits seen in the two European studies in patients who have failed all available treatment options. A sister study, FOXFIRE, is underway in the United Kingdom. Availability of hepatitis C testing at a given site is subject to change. HCCAP recommends calling a facility to verify the current availability of hepatitis C testing. The process involved before scheduling or visiting that facility. Beth may be a master when it comes to chess, but she proves less so when it comes to her personal life.
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