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
| NCT ID | NCT05354570 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Memorial Sloan Kettering Cancer Center |
| Condition | Thymic Malignancies |
| Study Type | INTERVENTIONAL |
| Enrollment | 36 participants |
| Start Date | 2022-04-26 |
| Primary Completion | 2027-04 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 36 participants in total. It began in 2022-04-26 with a primary completion date of 2027-04.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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
Contact & Investigator
Charles Simone, MD
PRINCIPAL INVESTIGATOR
Memorial Sloan Kettering Cancer Center
Frequently Asked Questions
Who can join the NCT05354570 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 79 Years, studying Thymic Malignancies. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05354570 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT05354570 currently recruiting?
Yes, NCT05354570 is actively recruiting participants. Contact the research team at simonec1@mskcc.org for enrollment information.
Where is the NCT05354570 trial being conducted?
This trial is being conducted at Basking Ridge, United States, Middletown, United States, Montvale, United States, Commack, United States and 3 additional locations.
Who is sponsoring the NCT05354570 clinical trial?
NCT05354570 is sponsored by Memorial Sloan Kettering Cancer Center. The principal investigator is Charles Simone, MD at Memorial Sloan Kettering Cancer Center. The trial plans to enroll 36 participants.