Intensity-Modulated Radiation Therapy for Thymic Cancer Spread to the Lungs
Phase II Study of Hemithoracic Intensity-Modulated Pleural Radiation Therapy (IMPRINT) for Patients With Pleural Metastases From Thymic Malignancies
This study is testing a new type of radiation therapy for patients with lung cancer spread from thymic tumors to see if it is safe and helps slow down cancer growth.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 36 (estimated) |
| Ages | 18 Years to 79 Years |
| Sex | All |
| Sponsor | Memorial Sloan Kettering Cancer Center Academic / other |
| Drugs / interventions | radiation, prednisone |
| Locations | 7 sites (Basking Ridge, New Jersey and 6 other locations) |
| Trial ID | NCT05354570 on ClinicalTrials.gov |
What this trial studies
This study investigates the safety and effectiveness of hemithoracic intensity-modulated pleural radiation therapy (IMPRINT) in patients with pleural metastases from thymic malignancies. Participants will receive IMPRINT treatment, and researchers will monitor for side effects and assess the treatment's impact on cancer progression. The study aims to provide insights into a potentially new therapeutic approach for this challenging condition.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 to 80 with confirmed thymic malignancy and evidence of pleural metastases, who meet specific health criteria.
Not a fit: Patients with extrathoracic metastatic disease or significant pulmonary function impairment may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could offer a safer and more effective option for patients with thymic cancer that has spread to the pleura.
How similar studies have performed: While this approach is novel, similar studies in radiation therapy for other cancers have shown promising results.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Basking Ridge, New Jersey and 6 other locations
- Memorial Sloan Kettering Basking Ridge (Limited protocol activities) — Basking Ridge, New Jersey, United States (Recruiting)
- Memorial Sloan Kettering Monmouth (Limited protocol activities) — Middletown, New Jersey, United States (Recruiting)
- Memorial Sloan Kettering Bergen (Limited protocol activities) — Montvale, New Jersey, United States (Recruiting)
- Memorial Sloan Kettering Suffolk - Commack (Limited protocol activities) — Commack, New York, United States (Recruiting)
- Memorial Sloan Kettering Westchester (Limited protocol activities) — Harrison, New York, United States (Recruiting)
- Memorial Sloan Kettering Cancer Center — New York, New York, United States (Recruiting)
- Memorial Sloan Kettering Nassau (Limited protocol activities) — Rockville Centre, New York, United States (Recruiting)
Study contacts
- Principal investigator: Charles Simone, MD — Memorial Sloan Kettering Cancer Center
- Study coordinator: Charles Simone, MD
- Email: simonec1@mskcc.org
- Phone: 212-639-3716
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.