Researchers are enrolling participants for a Phase III clinical trial to determine the relative benefits and survival rates of two procedures currently used to treat medical pleural effusion in pleural mesothelioma patients.
The trial will compare the outcomes of patients treated with either medical pleurodesis or video-assisted thoracoscopic (VATS) surgical pleuodectomy to determine which method offers greater benefit in terms of symptom control, quality of life, and survival rates.
Most mesothelioma patients experience shortness of breath as one of their earliest symptoms of the disease, as excess fluid collects around the lungs in a process known as pleural effusion. Currently, traditional medical treatment of pleural effusion has been to drain the excess fluid through a tube inserted into the chest cavity, followed by application of talc in the area between the lung and the pleura, the membrane which surrounds the lungs. The introduction of talc causes the lung to adhere closely to the pleura, effectively sealing the gap where the fluid would normally collect.
But in the last five years, VATS pleurectomy has emerged as a strong contender for the treatment of pleural effusion. In this procedure, the pleural membrane is removed through a video-assisted procedure which is less invasive than normal surgical pleurectomy, with potentially less damage to healthy surrounding tissues. Once the pleural membrane is removed, fluid cannot build up between it and the lungs. Because the procedure is relatively new, researchers hope to determine if the surgery involves greater risks that may outweigh any potential benefits of the treatment.
The study’s researchers will enroll 196 patients for the multi-center Phase III trial, which is scheduled to be completed by 2011. Participants will be randomized by computer to receive either procedure.
To be considered for the study participants must be at least 18 years of age and have confirmed or suspected mesothelioma of any subtype. Pleural effusion must be present in all participants. Participants must be healthy enough to undergo either procedure and may not have undergone a prior pleurodesis procedure. Participants with prior malignancy will be admitted to the study as long as the malignancy no longer requires treatment and the participant has a confirmed diagnosis of mesothelioma.
At the end of the study period, researchers hope to compare the effectiveness of the procedures with regard to 1-year survival rates, as well as determine which method:
In addition to regular health screenings conducted throughout the study period, participants will be asked to complete a series of quality of life questionnaires at 1-month, 3-month, 6-month, and 1-year intervals.
The study will be overseen by
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