Recruiting
Phase 2

IMPRINT

Sponsor:

Memorial Sloan Kettering Cancer Center

Code:

NCT05354570

Conditions

Thymic Malignancies

Pleural Metastases

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Intensity-Modulated Pleural Radiation Therapy (IMPRINT)

Study Details

Brief summary:

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.

Conditions

Thymic Malignancies

Pleural Metastases

Study ID

NCT05354570

Start date

Apr 26, 2022

Status verified date

May, 2026

Completion date

Apr, 2027

Anticipated

Primary completion date

Apr, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

36 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: 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.

Interventions

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.

Primary outcome measure

  • assess the rate of radiation pneumonitis [ Time Frame: 2 years ]

Central Contacts and Locations

Central contacts

Charles Simone, MD

212-639-3716simonec1@mskcc.org

Andrew Pagano, MD

paganoa@mskcc.org

Locations

Memorial Sloan Kettering Basking Ridge (Limited protocol activities)

Recruiting

Basking Ridge, New Jersey, United States, 07920

Contacts

Charles Simone, MD

212-639-3716

Memorial Sloan Kettering Monmouth (Limited protocol activities)

Recruiting

Middletown, New Jersey, United States, 07748

Contacts

Charles Simone, MD

212-639-3716

Memorial Sloan Kettering Bergen (Limited protocol activities)

Recruiting

Montvale, New Jersey, United States, 07645

Contacts

Charles Simone, MD

212-639-3716

Memorial Sloan Kettering Suffolk - Commack (Limited protocol activities)

Recruiting

Commack, New York, United States, 11725

Contacts

Charles Simone, MD

212-639-3716

Memorial Sloan Kettering Westchester (Limited protocol activities)

Recruiting

Harrison, New York, United States, 10604

Contacts

Charles Simone, MD

212-639-3716

Memorial Sloan Kettering Cancer Center

Recruiting

New York, New York, United States, 10065

Contacts

Charles Simone, MD

212-639-3716

Memorial Sloan Kettering Nassau (Limited protocol activities)

Recruiting

Rockville Centre, New York, United States, 11553

Contacts

Charles Simone, MD

212-639-3716

More Information

Sponsor

Memorial Sloan Kettering Cancer Center

Last update posted

May 6, 2026

Last verified

May, 2026

Keywords

  • Intensity-Modulated Pleural Radiation Therapy (IMPRINT)
  • 22-098

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Memorial Sloan Kettering Cancer Center on 2026-05-06.