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IMPRINT for Thymic Cancer with Pleural Metastases

This study is looking at a treatment called Intensity-Modulated Pleural Radiation Therapy (IMPRINT) for people with thymic cancer that has spread to the lining of the lungs and chest (pleural metastases). Researchers want to see if IMPRINT is safe and causes few or mild side effects. They will also check how well it works against the cancer. You might be able to join if you are between 18 and 79 years old, have a confirmed diagnosis of thymic cancer, and have evidence of cancer spread to the pleura. The main goal is to measure the rate of a lung side effect called radiation pneumonitis after two years. The current status of this study is unclear.

Study design
This study is an interventional study planning to enroll 36 participants. It is not specified if it is randomized or blinded.
What's involved
You would receive radiation therapy over approximately 6 weeks. This involves 28 treatment sessions.
Compensation
Not stated in the trial record.
Follow-up
Researchers will assess a specific side effect (radiation pneumonitis) for up to 2 years after treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05354570

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

Recruiting
PHASE2Ages 18–79InterventionalTreatment
Memorial Sloan Kettering Cancer Center
~36 participants
Updated 2026-05-06 on ClinicalTrials.gov
What's tested:Intensity-Modulated Pleural Radiation Therapy (IMPRINT)

At a glance

Recruiting sites
7 of 7 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
assess the rate of radiation pneumonitis
Measured over 2 years

Conditions

Thymic Malignancies
Pleural Metastases

Explore related trials

Malignant Thymus NeoplasmMetastatic Malignant Neoplasm in the Pleura

Where it's being run

7 sites across 2 states
New York4
New Jersey3

Study leadership

  • Charles Simone, MD · PRINCIPAL_INVESTIGATOR · Memorial Sloan Kettering Cancer Center

Who to contact

Charles Simone, MD
[email protected]
212-639-3716
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • assess the rate of radiation pneumonitis2 years

    as indicated by the rate of grade 3 or higher radiation pneumonitis defined by the NCI Common Terminology Criteria (CTC) version 5.0.