An official website of the United States government
Government Funding Lapse Because of a lapse in government funding, the information on this website may not be up to date, transactions submitted via the website may not be processed, and the agency may not be able to respond to inquiries until appropriations are enacted.
The NIH Clinical Center (the research hospital of NIH) is open. For more details about its operating status, please visit cc.nih.gov.
Updates regarding government operating status and resumption of normal operations can be found at opm.gov.
A Study of Intensity-Modulated Pleural Radiation Therapy in People with Thymic Cancer That Has Spread to the Lining of the Lungs and Chest
Trial Status: active
This phase II trial tests whether intensity-modulated pleural radiation therapy (IMPRINT) works to shrink tumors in patients with thymic cancer that has spread to the lining of the lungs and chest. IMPRINT is a type of radiation therapy that specifically targets the lining of the lungs and the inner side of the ribs to stop cancer from growing. By targeting only these areas, IMPRINT reduces the risk of damage to the lungs, and reduces the chance of cancer returning. IMPRINT may shrink or stabilize cancer in patients with mesothelioma or other types of cancer that form in the lungs, or heart, but it is not typically used in people with pleural metastases from thymic malignancies.
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 hemoglobin [Hgb])
Forced expiratory volume in 1 second (FEV1) >= 35% (corrected for Hgb)
Glomerular filtration rate (GFR): >= 50 mL/min/1.73 m^2 (must be calculated using estimated creatinine clearance (CrCl) by the Cockcroft-Gault (C-G) equation
* 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 teh past 6 months.
Prior nephrectomy on the contralateral side of the pleural metastases
Prior thoracic radiation therapy preventing hemithoracic pleural intensity-modulated radiation therapy (IMRT). Prior thymic bed radiation is allowed. Prior pleural stereotactic body radiation therapy (SBRT) is allowed
Patients undergoing extrapleural pneumonectomy. Other surgical resection approaches of the pleural nodules (ex: pleurectomy/decortication [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
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
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
Additional locations may be listed on ClinicalTrials.gov for NCT05354570.
Locations matching your search criteria
United States
New Jersey
Basking Ridge
Memorial Sloan Kettering Basking Ridge
Status: Active
Contact: Charles B. Simone
Phone: 212-639-3716
Middletown
Memorial Sloan Kettering Monmouth
Status: Active
Contact: Charles B. Simone
Phone: 212-639-3716
Montvale
Memorial Sloan Kettering Bergen
Status: Active
Contact: Charles B. Simone
Phone: 212-639-3716
New York
Commack
Memorial Sloan Kettering Commack
Status: Active
Contact: Charles B. Simone
Phone: 212-639-3716
New York
Memorial Sloan Kettering Cancer Center
Status: Active
Contact: Charles B. Simone
Phone: 212-639-3716
Uniondale
Memorial Sloan Kettering Nassau
Status: Active
Contact: Charles B. Simone
Phone: 212-639-3716
West Harrison
Memorial Sloan Kettering Westchester
Status: Active
Contact: Charles B. Simone
Phone: 212-639-3716
PRIMARY OBJECTIVE:
I. To determine the rate of grade 3 or higher radiation pneumonitis within 4 months from the completion of IMPRINT in patients undergoing hemithoracic IMPRINT.
SECONDARY OBJECTIVES:
I. To assess the incidence of any radiation related grade 2 or greater toxicity using Common Terminology Criteria for Adverse Events (CTCAE) version (v)5.
II. To assess progression-free survival.
III. To determine the patterns of failure and disease recurrence after hemithoracic IMPRINT.
IV. To assess overall survival.
V. To determine the impact of hemithoracic IMPRINT on patient reported outcomes (patient reported outcome [PRO]CTCAE).
OUTLINE:
Patents undergo radiation therapy (IMPRINT) once daily (QD) 5 days a week (Monday through Friday) for 6 weeks in the absence of disease progression or unacceptable toxicity. Patients also undergo blood sample collection, computed tomography (CT) scan, Fludeoxyglucose F-18 (FDG) positron emission tomography (PET) scan, pulmonary function tests with diffusion capacity of the lung for carbon monoxide (DLCO) on study.
After completion of study treatment, patients are followed up at 30 days, 4 months, and 12 months after last day of IMPRINT and then every 6 or 12 months thereafter.
Trial PhasePhase II
Trial Typetreatment
Lead OrganizationMemorial Sloan Kettering Cancer Center
