Phase II Mesothelioma Clinical Trial Involving Radiation Therapy Actively Recruiting Patients
The second phase of a clinical trial is actively recruiting patients diagnosed with malignant pleural mesothelioma. The study is using a multimodal treatment approach involving surgery, radiation therapy, and chemotherapy, and has spaces available for 81 eligible participants.
Researchers at Memorial Sloan-Kettering Cancer Center and other locations across the U.S. and Canada will combine a mesothelioma surgery called pleurectomy with decortication, then apply specific chemotherapy drugs, and radiation therapy. Their goal: to reduce tumor growth and prevent cancer cells from spreading to other areas of the body. The trial will test a new type of radiation therapy, which may be easier for patients to tolerate compared to traditional radiation treatments.
Curative treatment for mesothelioma already involves a multimodal treatment plan. Researchers hope the results of this study will demonstrate a new way to use radiation therapy and reduce the occurrence of common side effects.
Radiation therapy uses high-energy particle beams to destroy cancer cells in specific areas of the body. Standard mesothelioma treatment does not typically involve the use of radiation due to severe side effects, including damage to the lungs.
Researchers believe a new radiation technique called Intensity Modulated Radiation Therapy (IMRT), which targets the lining of the lung, may reduce several side effects of standard radiation therapy, including damage to the lungs or immune system stress.
For most new treatment options, the Federal Drug Administration (FDA) must approve it after several phases of clinical trials. For this study, doctors will collect data to determine the effectiveness and side effects of IMRT.
Surgeons will perform a pleurectomy, a type of surgery that removes tumors in the pleura, or lining of the lungs. Once the procedure is complete, patients will receive adjuvant chemotherapy, which is designed to stop the growth of the mesothelioma tumors. Finally, the radiation treatments are applied directly to the pleura to destroy any remaining tumors and surrounding cancer cells.
Researchers also designated a secondary objective, which involves comparing local recurrence (cancer that has come back) with metastatic disease (cancer that has spread). They’ll use the results of this study to establish a pattern between the two.
The study will also help researchers develop a prediction model of resectability and a prognostic multi-modality imaging model through MRI, PET, and CT imaging. A successful prediction model could help doctors predict the success of tumor-removing surgery on cancer patients.
Study Requirements and Process
Study patients must be eligible for surgery and will undergo a pleurectomy, which removes part of the pleura using standard techniques.
Several weeks later, study subjects will receive the chemotherapy drugs pemetrexed and cisplatin or carboplatin intravenously (IV). Patients will repeat treatment every 21 days for up to four courses.
One to two months after completing chemotherapy, subjects will begin radiation therapy (IMRT) for up to six weeks. Following the treatment, patients will follow up with researchers after one month, then every three months for two years.
Researchers estimate the trial, which began in 2008, will be completed in July 2020.
Sponsors of the study include Memorial Sloan Kettering Cancer Center, M.D. Anderson Cancer Center, Princess Margaret Hospital in Canada, Mayo Clinic, and Brigham and Women’s Hospital.
If you are interested in participating, talk to your doctor about your eligibility. To learn more about this trial and locate other studies involving pleural mesothelioma, visit ClinicalTrials.gov.