The Lung-Sparing Combined Modality Protocol, which has entered its secondary phase, is currently recruiting patients. The trial, started in February 2008, is estimated for completion in December 2014. It was last updated on clinicaltrial.gov on May 9, 2010 and has an estimated enrollment of 48 patients. The study seeks to determine the overall one-year mesothelioma survival rate.
The implication of this study is considerable. If research is able to prove that major lung cancer surgery is no longer the only and most effective solution, then perhaps a new treatment combining judicious preparative surgery, systemic chemotherapy and locoregional drug treatment may offer the best hope for the extension of mesothelioma patient survival.
The study’s objective is threefold: to assess the toxicity of a trimodal lung therapy; to compare the toxicities with or without the systemic chemotherapy; and to determine whether systemic chemotherapy has an impact on the survival rate among patients with pleural mesothelioma.
Pleural mesothelioma is a rare type of cancer in which malignant cells are found in the pleura (a thin layer that lines the chest). Exposure to airborne asbestos particles increases one's chances of contracting pleural mesothelioma. Mesothelioma chemotherapy is usually the most effective treatment, but it may be replaced and/or combined with surgery and radiation therapy. The drugs commonly used to treat mesothelioma include Cisplatin, Doxorubicin, Doxorubicin hydrochloride, Pemetrexed and Pemetrexed disodium.
Two different interventions are to be realized within the study. The first consists of intrapleural chemotherapy in addition to systemic chemotherapy. First, a thoracoscopy will be performed in order to implant two intrapleural catheters. Second, an intrapleural therapy containing Cisplatin and Doxorubicin will be administered during week 1, 2, 4, 5, 7 and 8 of the treatment. Third, a systemic chemotherapy treatment with Cisplatin and Pemetrexed will be administered during weeks 3, 6 and 9. Finally, three weeks after the last dose of chemotherapy and 11 to 12 weeks after the thoracoscopy, intrapleural radiotherapy with P-32 will be given.
The second intervention is similar to the first in that an exploratory thoracoscopy, intrapleural therapy and intrapleural radiotherapy are preformed. However, for comparative reasons, no systemic therapy is carried out.
Patients must be 18 years to 75 years of age in order to participate in the trial. The study is open to both genders provided they have confirmed pleural mesothelioma. Applicants should make sure that they are ineligible for other high priority national or institutional study, their mesothelioma is less than 20% of the sarcomatoid type and their life expectancy is longer than three months. Finally, it is essential for the purpose of the study that there be no radiographic or other imaging evidence of Stage IV (cardiac, mediastinal, peritoneal, other distant) disease.
For more information on the trial or trial organization contact information, visit:
http://clinicaltrials.gov/ct2/show/NCT00859495?term=pleural+mesothelioma&rank=10
Please refer to this trial by its ClinicalTrials.gov identifier: NCT00859495.
Mesothelioma.com recommends that all mesothelioma patients speak with their oncologist regarding their potential inclusion in a mesothelioma clinical trial. Not all patients will be eligible, but for those who are, experimental techniques may have great benefit and can increase mesothelioma survival rate.
