Enrollment is open for a new mesothelioma trial run by Memorial Sloan Kettering Cancer Center to test a three-prong approach to treatment.
Pleural mesothelioma is a lung-related cancer caused by asbestos. It is notoriously difficult to treat and highly aggressive.
The new mesothelioma trial aims to recruit 150 pleural mesothelioma patients. Patients will receive lung-sparing surgery and chemotherapy. Some will also receive intensity modulated radiation therapy (IMRT).
Researchers will test which group does better – those who only have surgery and chemotherapy or those who also have targeted radiation therapy. They plan to measure not only survival but also complications, quality of life, and how long it takes for the cancer to come back.
Tri-Modal Treatment to Fight Mesothelioma
The new mesothelioma trial will attempt to answer some questions about the disease and its treatment. Doctors have known for a long time that pleural mesothelioma rarely responds to one kind of therapy. Mesothelioma patients who have the best survival are those who have at least two kinds of treatments.
But not all patients are candidates for a multi-modality approach. Some mesothelioma patients are too sick for anything but chemotherapy. Mesothelioma chemotherapy can help slow the growth of tumors but it is not a cure.
Patients who are well enough may have surgery. One type of mesothelioma surgery (EPP) involves removing one of the lungs. The other type (P/D) leaves both lungs intact but removes other at-risk tissues.
The new mesothelioma trial focuses on P/D. Some studies show that survival is better with this more conservative type of surgery. Both types of surgery achieve the best outcomes when they are done at a higher-volume medical center.
Who is Eligible for the New Mesothelioma Trial?
The new mesothelioma trial is looking for newly diagnosed mesothelioma patients. Patients must be candidates for surgery and chemotherapy. Most patients will have chemotherapy after surgery (adjuvant). Some may have chemotherapy before surgery (neoadjuvant) in an effort to shrink the tumor before removal.
Within 8 weeks of their last treatment, patients will be randomly assigned to one of two groups. One group will get radiation with IMPRINT. IMPRINT stands for intensity modulated pleural radiation therapy. It is a type of highly targeted radiotherapy developed at Memorial Sloan Kettering. Targeted radiotherapy is less likely to impact healthy tissue and trigger side effects.
The second group in the new mesothelioma trial will have no further treatment.
“The primary endpoint of the study is overall survival,” writes radiation oncologist Andreas Rimner, MD. “Secondary endpoints include local failure-free, distant-metastases free and progression-free survival, treatment-related toxicities, and change in quality-of-life.”
Sixteen hospitals have been approved to offer the new mesothelioma trial. Another 46 sites are pending approval. Researchers hope to have some answers by July of 2025.
Rimner, A, et al, “A Phase III Randomized Trial of Pleurectomy/Decortication Plus Chemotherapy With or Without Adjuvant Hemithoracic Intensity-Modulated Pleural Radiation Therapy (IMPRINT) for Malignant Pleural Mesothelioma (MPM) (NRG LU-006)”, November 1, 2021, International Journal of Radiation Oncology, Biology, Physics, Volume 111, Issue 3, Supplement, https://www.redjournal.org/article/S0360-3016(21)02168-4/fulltext#relatedArticles
“Testing the Addition of Targeted Radiation Therapy to Surgery and the Usual Chemotherapy Treatment (Pemetrexed and Cisplatin [or Carboplatin]) for Stage I-IIIA Malignant Pleural Mesothelioma”, ClinicalTrials.gov Identifier: NCT04158141, https://clinicaltrials.gov/ct2/show/NCT04158141?term=IMPRINT&recrs=ab&cond=pleural+mesothelioma&cntry=US&draw=2&rank=2