NCT04158141

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

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)

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: NRG Oncology · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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. After completion of study treatment, patients are followed up every 3 months for 2 years, then every 6 months for 3 years.

Conditions

• Pleural Biphasic Mesothelioma
• Pleural Epithelioid Mesothelioma
• Stage I Pleural Malignant Mesothelioma AJCC v8
• Stage IA Pleural Malignant Mesothelioma AJCC v8
• Stage IB Pleural Malignant Mesothelioma AJCC v8
• Stage II Pleural Malignant Mesothelioma AJCC v8
• Stage IIIA Pleural Malignant Mesothelioma AJCC v8

Interventions

Type	Name	Description
DRUG	Carboplatin	Intravenously
DRUG	Cisplatin	Intravenously
PROCEDURE	Decortication	Undergo decortication
RADIATION	Intensity-Modulated Radiation Therapy	Daily fractions
DRUG	Pemetrexed	Intravenously
DRUG	Pemetrexed Disodium	Intravenously
RADIATION	Pencil beam scanning proton therapy	Daily fractions
PROCEDURE	Pleurectomy	Undergo pleurectomy

Timeline

• Start date: 2020-01-29
• Primary completion: 2023-11-20
• Completion: 2023-11-20
• First posted: 2019-11-08
• Last updated: 2025-02-19
• Results posted: 2025-02-19

Locations

27 sites across 2 countries: United States, Canada

Regulatory

• FDA-regulated drug study