A Study of Intensity-Modulated Pleural Radiation Therapy (IMPRINT) in People With Thymic Cancer That Has Spread to the Lining of the Lungs and Chest

Study Overview
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Brief Summary
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The researchers are doing this study to find out whether hemithoracic intensity-modulated pleural radiation therapy (IMPRINT) is a safe treatment that causes few or mild side effects in people with pleural metastases from thymic malignancies. The researchers will also look at whether hemithoracic IMPRINT is effective against participants' cancer.

Official Title
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Phase II Study of Hemithoracic Intensity-Modulated Pleural Radiation Therapy (IMPRINT) for Patients With Pleural Metastases From Thymic Malignancies

Conditions
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Thymic Malignancies, Pleural Metastases

Intervention / Treatment
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* Radiation: Intensity-Modulated Pleural Radiation Therapy (IMPRINT)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Provide written informed consent to participate on the study Patients must have a pathologically confirmed diagnosis of thymic malignancy. Thymic carcinoma is allowed. Patients must have radiologic or pathologic evidence of pleural metastases. Patients may have de novo stage IVA or recurrent disease in the pleura. Gross disease in the fissure is allowed if resected. No evidence of extrathoracic metastatic disease or contralateral pleural/pericardial disease. Patient age ≥ 18 years but ≤ 80 years at the time of consent Karnofsky performance status ≥ 80% Preoperative or Postoperative Pulmonary Function Tests: DLCO > 40% predicted (corrected for Hgb) and FEV1 ≥ 35% (corrected for Hgb) Glomerular filtration rate (GFR): ≥50 mL/min/1.73 m2 (must be calculated using estimated creatinine clearance (CrCl) by the Cockcroft-Gault (C-G) equation (Nephron 1976;16:31-41): CrCl (mL/min) = [140 - age (years)] x weight (kg) [x 0.85 for female patients] 72 x serum creatinine (mg / dL) ° In cases of concern about decreased renal function and potential high radiation dose to the kidneys, an optional nuclear medicine kidney function scan may be performed prior to radiation therapy to determine the functional contribution of each kidney. Exclusion Criteria: Continuous oxygen use Patients with an acute flare of myasthenia gravis requiring addition of new medication in the past 6 months Prior nephrectomy on the contralateral side of the pleural metastases Prior thoracic radiation therapy preventing hemithoracic pleural IMRT. Prior thymic bed radiation is allowed. Prior pleural SBRT is allowed. Patients undergoing extrapleural pneumonectomy. Other surgical resection approaches of the pleural nodules (ex: P/D, debulking/metastasectomy) are allowed. Surgical resection of the primary thymic tumor is allowed. Acute congestive heart failure requiring hospitalization within the past 30 days. COPD requiring chronic oral steroid therapy of > 10 mg prednisone daily or equivalent at the time of registration. Inhaled corticosteroids are allowed Unstable angina requiring hospitalization and/or transmural myocardial infarction within the last 3 months History of interstitial lung disease Pregnant or lactating women Men or women not using effective contraception

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 79 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: This is a single-arm Phase II single institution trial.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hemithoracic Intensity-Modulated Pleural Radiation Therapy (IMPRINT)<br>Radiation will be administered over approximately 6 weeks to 50.4 Gy in 28 fractions with an optional SIB to gross residual disease. | Radiation: Intensity-Modulated Pleural Radiation Therapy (IMPRINT)<br>* Radiation therapy will be administered over approximately 6 weeks at 50.4 Gy in 28 fractions, including an optional dose-painting SIB to gross residual disease up to 60 Gy while respecting normal tissue constraints.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| assess the rate of radiation pneumonitis | as indicated by the rate of grade 3 or higher radiation pneumonitis defined by the NCI Common Terminology Criteria (CTC) version 5.0. | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| progression-free survival (PFS) | PFS events will include death and/or progression of thymic malignancy due to local-regional or distant recurrence/progression. PFS will be calculated from the start of radiation treatment and will be estimated by the Kaplan-Meier method. | 12 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Intensity-Modulated Pleural Radiation Therapy (IMPRINT), 22-098