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

Memorial Sloan Kettering Cancer Center (MSK)

Status and phase

Enrolling

Phase 2

Conditions

Thymic Malignancies

Pleural Metastases

Treatments

Radiation: Intensity-Modulated Pleural Radiation Therapy (IMPRINT)

Study type

Interventional

Funder types

Other

Identifiers

NCT05354570

22-098

Details and patient eligibility

About

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.

Enrollment

36 estimated patients

Sex

All

Ages

18 to 79 years old

Volunteers

No Healthy Volunteers

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