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
NCT ID: NCT05354570
Last Updated: 2025-07-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
36 participants
INTERVENTIONAL
2022-04-26
2026-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Hemithoracic Intensity-Modulated Pleural Radiation Therapy (IMPRINT)
Radiation will be administered over approximately 6 weeks to 50.4 Gy in 28 fractions with an optional SIB to gross residual disease.
Intensity-Modulated Pleural Radiation Therapy (IMPRINT)
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.
Interventions
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Intensity-Modulated Pleural Radiation Therapy (IMPRINT)
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
79 Years
ALL
No
Sponsors
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Memorial Sloan Kettering Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Charles Simone, MD
Role: PRINCIPAL_INVESTIGATOR
Memorial Sloan Kettering Cancer Center
Locations
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Memorial Sloan Kettering Basking Ridge (Limited protocol activities)
Basking Ridge, New Jersey, United States
Memorial Sloan Kettering Monmouth (Limited protocol activities)
Middletown, New Jersey, United States
Memorial Sloan Kettering Bergen (Limited protocol activities)
Montvale, New Jersey, United States
Memorial Sloan Kettering Suffolk - Commack (Limited protocol activities)
Commack, New York, United States
Memorial Sloan Kettering Westchester (Limited protocol activities)
Harrison, New York, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Memorial Sloan Kettering Nassau (Limited protocol activities)
Rockville Centre, New York, United States
Countries
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Central Contacts
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Facility Contacts
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Charles Simone, MD
Role: primary
Charles Simone, MD
Role: primary
Charles Simone, MD
Role: primary
Charles Simone, MD
Role: primary
Charles Simone, MD
Role: primary
Charles Simone, MD
Role: primary
Charles Simone, MD
Role: primary
Related Links
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Memorial Sloan Kettering Cancer Center
Other Identifiers
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22-098
Identifier Type: -
Identifier Source: org_study_id
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