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Clinical Trial 20722

Cancer Type: Thoracic
Study Type: Treatment
NCT#: NCT04158141

Phase: Phase III
Principal Investigator: Perez, Bradford

Call 813-745-6100
or 1-800-679-0775 Learn More

Overview

Study Title

Phase III Randomized Trial of Pleurectomy/Decortication plus Chemotherapy with or without Adjuvant Hemithoracic Intenstiy-Modulated Pleural Radiation Therapy (IMPRINT) for Malignant Pleural Mesothelioma (MPM)

Summary

his 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.

Objective

Primary Objective To detect an improvement in overall survival with the addition of adjuvant hemithoracic IMPRINT to surgery and chemotherapy compared to surgery and chemotherapy alone.

Treatments

Therapies

Radiotherapy; Surgery; Therapy (NOS)

Medications

Inclusion Criteria

Inclusion Criteria: PRIOR TO STEP 1 REGISTRATION INCLUSION CRITERIA

Pathologically (histologically or cytologically) confirmed diagnosis of epithelioid or biphasic malignant pleural mesothelioma (MPM) within 90 days prior to Step 1 Registration

Imaging proof of clinical stage (American Joint Committee on Cancer [AJCC] 8th edition) I-IIIA MPM by PET/CT within 42 days prior to Step 1 Registration

MPM is amenable to resection by P/D as determined by a thoracic surgeon within 42 days prior to Step 1 Registration

History/physical examination within 42 days prior to Step 1 Registration

Karnofsky performance status >= 80 within 42 days prior to Step 1 Registration

Pulmonary function tests within 42 days prior to Step 1 Registration as outlined per protocol

Organ function and bone marrow function lab values as identified per protocol

Negative serum pregnancy test within 14 days of Step 1 Registration for pre-menopausal women of childbearing potential

The patient or a legally authorized representative must provide study-specific informed consent prior to study entry

EORTC QLQ-C30 and QLQ-LC13 within 42 days prior to Step 1 Registration PRIOR TO STEP 2 RANDOMIZATION INCLUSION CRITERIA

Patients must have received at least 2 cycles of pemetrexed/platinum chemotherapy and undergone a pleurectomy/decortication with the goal of macroscopic complete resection following step 1 Registration

Karnofsky performance status >= 70 within 30 days prior to Step 2 Randomization

History/physical examination within 30 days prior to Step 2 Randomization

EORTC QLQ-C30 and QLQ-LC13 within 30 days prior to Step 2 Randomization

Exclusion Criteria

Exclusion Criteria: PRIOR TO STEP 1 REGISTRATION EXCLUSION CRITERIA

Pregnant or lactating women, or sexually active men or women not using effective contraception (risk for fetal defects from teratogenic chemotherapy and radiation therapy) within 14 days prior to Step 1 Registration

Diagnosis of sarcomatoid mesothelioma

Severe, active co-morbidity defined as follows: (1) New York Heart Association (NYHA) class III or IV heart failure (2) Chronic obstructive pulmonary disease (COPD) requiring chronic oral steroid therapy of > 10 mg prednisone daily or equivalent at the time of registration. Inhaled corticosteroids are allowed; (3) Unstable angina requiring hospitalization and/or transmural myocardial infarction within the last 3 months; (4) Interstitial lung disease; (5) Hemodialysis or peritoneal dialysis; (6) Concurrent active malignancy (with the exception of current or prior non-melanomatous skin cancer or low-grade malignancies followed observantly for which treatment has not or does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen)

If evidence of disease > Hepatic impairment defined by ChildPugh class (ChildPugh class B & C);

For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy within 30 days prior to registration, if indicated. Note: HBV viral testing is not required for eligibility for this protocol

Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load within 30 days prior to registration

Active tuberculosis

Patients on immunosuppressive therapy, for example history of organ or bone marrow transplant or chronic lymphocytic leukemia (CLL);

CD4 count = 200 cells/microliter within 30 days prior to registration. Note also that HIV testing is not required for eligibility for this protocol

Prior nephrectomy on the contralateral side of MPM

Ipsilateral thoracic electronic implant, e.g. pacemaker, defibrillator, unless switched to the contralateral side prior to initiation of radiation therapy (RT)

Prior thoracic radiation therapy (patients with prior thoracic RT cannot be planned to 50-60 Gy without exceeding normal tissue constraints) PRIOR TO STEP 2 RANDOMIZATION EXCLUSION CRITERIA

Progressive disease

Supplemental oxygen use

Third space fluid that cannot be controlled by drainage or insufficient lung expansion after P/D (this prevents targeting the pleura without exceeding normal tissue constraints)

Prior intrapleural therapy (i.e. intrapleural chemotherapy, photodynamic therapy); pleurodesis is permitted

Bulky residual disease in the major fissure preventing pleural IMRT

Patients who have undergone extrapleural pneumonectomy

Patients with active infection that requires systemic I.V. antibiotics, antiviral, or antifungal treatments

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