Clinical Trial to Compare Survival Rates, Quality of Life in Mesothelioma Patients

Phase III trial to measure outcome of talc pleurodesis and video-assisted thorascopic cytoreductive pleuroectomy

Syracuse, NY 8/14/2009 01:35 AM GMT (TransWorldNews)

Researchers at Papworth Hospital and several other medical facilities in Great Britain are enrolling participants in a Phase III clinical trial to compare the efficacy of talc pleurodesis to a minimally invasive surgical procedure, called video-assisted thorascopic (VAT) cytoreductive pleurectomy, in patients with malignant mesothelioma.


This phase of the study is designed to determine if either technique is associated with higher one-year survival rates, and is also designed to determine if either technique offers better control of pleural effusion, a condition which causes a build up of fluid around the lungs.


Both techniques are currently used in mesothelioma treatment, and are designed to target the pleura, the membrane or sac which surrounds the lungs. In men and women with pleural mesothelioma, fluid often collects in the pleural area, interfering with normal breathing. In talc pleurodesis, the surgeon injects talc between the two layers of the pleura, irritating them and causing them to adhere to each other, and closing the pleural space where fluid builds up.


Cytoreductive pleurectomy involves the partial or complete removal of the pleural membrane using a surgical technique. The procedure can be performed through an open chest incision, or by using the VAT technique, a minimally invasive procedure which gained widespread popularity in the 1990s. This method uses small incisions to access the chest cavity, allowing insertion of tiny cameras as well as surgical intruments. Surgeons are able to both view the chest cavity and perform certain surgical procedures through these tiny incisions, resulting in fewer side effects and less downtime than traditional “open” procedures requiring large incisions.


Other secondary outcomes being compared during the trial include procedure-related complications; quality of life at 3-, 6-, and 12-month intervals; and overall healthcare-associated costs. Men and women with diagnosed or suspected mesothelioma may be selected to participate in the trial as long as they have never undergone an attempted pleurodesis procedure in the past.


In qualifying patients, the VATS or pleurodesis procedure may be performed at the time of biopsy or once diagnosis has been confirmed.


Researchers hope to enroll 196 patients in the trial. In addition to the primary location at Papworth, hospitals in London, Basildon, Sheffield, and Leicester are also participating in the study.


Papworth Hospital, located in Cambridgeshire, England, is the largest cardiothoracic center in the UK, and also serves as the UK’s main organ transplant facility. Dr. Robert Winter, an adult respiratory medicine specialist and mesothelioma cancer clinical researcher, practices medicine at Papworth and also serves as the Medical Director for the UK National Health Service [NHS] for the Eastern England division, a position he has held since January 2008.


Mesothelioma is a rare form of cancer that affects the mesothelium, the membrane that surrounds the body’s internal organs. The most common type of mesothelioma, pleural mesothelioma, affects the membrane surrounding the lungs. Mesothelioma cancer can also occur in the abdominal cavity and the membrane surrounding the heart. These conditions are referred to as peritoneal mesothelioma and pericardial mesothelioma, respectively.


The development of mesothelioma cancer is associated with exposure to asbestos, developing after tiny inhaled particles of asbestos are inhaled or ingested, lodging in the chest or abdominal cavity. These particles cause genetic changes in the cells of the mesothelium over time. Symptoms of mesothelioma may not become apparent until years- even decades – after exposure to the mineral, and include persistent cough, chest pain, and shortness of breath.


For many years, asbestos was a part of literally thousands of products in the construction, shipbuilding, automotive, and HVAC industries, and is still present in millions of homes, buildings, and ships. In the mid-1980s, legislation was passed banning the use of asbestos in the manufacturing process. However, frequent exposure to the fibers still occurs as materials containing the product degrade over time. As a result, even simple home renovation tasks can put individuals at risk for exposure.


For patients outside of the United States who are interested in learning more about this clinical trial or the mesothelioma treatment options available at Papworth Hospital, please visit or call the hospital directly: 01480 830541.


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