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NCT Number: 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

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.

Recruiting

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Key information

Age range

18 year–79 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Memorial Sloan Kettering Basking Ridge (Limited protocol activities), Basking Ridge, New Jersey, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Intensity-Modulated Pleural Radiation Therapy (IMPRINT)

Radiation

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 outcomes

  1. assess the rate of radiation pneumonitis

    Time frame: 2 years

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

Secondary outcomes

  1. progression-free survival (PFS)

    Time frame: 12 month

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Andrew Pagano, MD

CONTACT

[email protected]

Charles Simone, MD

CONTACT

[email protected]

212-639-3716

Sponsors and collaborators

Lead sponsor

Memorial Sloan Kettering Cancer Center

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2027
Study completion
2027
First posted
Apr 29, 2022
Registry last updated
May 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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