Pleural Biphasic Mesothelioma Clinical Trial
Official title:
Phase III Randomized Trial of Pleurectomy/Decortication Plus Systemic Therapy With or Without Adjuvant Hemithoracic Intensity-Modulated Pleural Radiation Therapy (IMPRINT) for Malignant Pleural Mesothelioma (MPM)
This trial studies how well the addition of targeted radiation therapy to surgery and the usual chemotherapy treatment works for the treatment of stage I-IIIA malignant pleural mesothelioma. Targeted radiation therapy such as intensity-modulated radiation therapy or pencil beam scanning uses high energy rays to kill tumor cells and shrink tumors. Drugs used in chemotherapy, such as pemetrexed, cisplatin, and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving targeted radiation therapy in addition to surgery and chemotherapy may work better than surgery and chemotherapy alone for the treatment of malignant pleural mesothelioma.
PRIMARY OBJECTIVE: I. To detect an improvement in overall survival with the addition of adjuvant hemithoracic intensity-modulated pleural radiation therapy (IMPRINT) to surgery and chemotherapy compared to surgery and chemotherapy alone. SECONDARY OBJECTIVES: I. To determine local failure-free survival, distant-metastases-free survival, and progression-free survival with the addition of adjuvant hemithoracic IMPRINT to surgery and chemotherapy compared to surgery and chemotherapy alone. II. To evaluate the treatment-related toxicities in both arms per Common Terminology Criteria for Adverse Events (CTCAE) version (v)5.0. III. To detect a clinically meaningful 10-point change in global health status mean scores at 9 months after randomization with the addition of adjuvant IMPRINT as compared to surgery and chemotherapy alone. EXPLORATORY OBJECTIVES: I. To evaluate the degree of under-staging, concordant and upstaging between centrally-reviewed clinical staging (based on positron emission tomography [PET], computed tomography [CT] and/or magnetic resonance imaging [MRI]) and pathologic staging. II. To identify immunologic and pathologic biomarkers as predictors of response and potential targets for future combination trials. III. To determine the magnitude of radiation dose escalation to gross residual disease based on combined modality imaging and associated local control rates with dose-painting intensity-modulated radiation therapy (IMRT). IV. To determine the rate of R0/R1 and R2 resections, and type of procedures (extended pleurectomy/decortication [P/D], P/D and partial pleurectomy). V. To evaluate the trajectory of European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-Q30) and lung cancer specific module (LC13) symptoms in patients treated with IMPRINT by comparing the proportion of patients who respond with "quite a bit" or "very much" LC13 symptoms at 9-12 months post-randomization compared to at 3 months post-randomization. VI. To evaluate changes in health-related quality of life, functional domains, and symptoms over time with the addition of adjuvant IMPRINT as compared to surgery and chemotherapy alone. OUTLINE: STEP 1: Patients undergo P/D then within 4 to 8 weeks receive pemetrexed intravenously (IV) over 10 minutes and cisplatin or carboplatin IV over 60 minutes on day 1. Patients may instead receive pemetrexed IV over 10 minutes and cisplatin or carboplatin IV over 60 minutes on day 1 then undergo P/D within 4 to 8 weeks after chemotherapy. The order of surgery and chemotherapy is at the discretion of the treating physician. STEP 2: Within 4 to 8 weeks from the end of Step 1 treatment, patients are randomized to 1 of 2 arms. ARM I: Patients receive no treatment. ARM II: Patients undergo 25-28 fractions IMRT or pencil beam scanning (PBS) proton therapy 5 days per week over 6 weeks. After completion of study treatment, patients are followed up every 3 months for 2 years, then every 6 months for 3 years. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Terminated |
NCT02672033 -
Accelerated Hypofractionated Radiation Therapy Immediately Before Surgery in Treating Patients With Malignant Pleural Mesothelioma
|
N/A | |
| Active, not recruiting |
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Pembrolizumab in Treating Patients With Malignant Mesothelioma
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Phase 2 |