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

Launched by MEMORIAL SLOAN KETTERING CANCER CENTER · Apr 26, 2022

Keywords

ClinConnect Summary

This clinical trial, called IMPRINT, is exploring a new treatment method called intensity-modulated pleural radiation therapy (IMPRINT) for people with thymic cancer that has spread to the lining of the lungs and chest. The main goal of the study is to determine if this treatment is safe and has manageable side effects, while also assessing how effective it is in fighting the cancer. Researchers are looking for participants who are between 18 and 80 years old, have been diagnosed with thymic malignancy, and have specific evidence of cancer spreading to the pleural area (the lining around the lungs).

If you or a loved one are interested in participating, you'll need to provide written consent and meet certain health criteria, such as having good lung function and no other major health issues that could complicate treatment. Participants can expect to receive this specialized radiation therapy and will be closely monitored for safety and effectiveness. It's essential to know that there are specific exclusions, so not everyone with thymic cancer will qualify. The study is currently recruiting participants, and your involvement could contribute to important advancements in treatment for this type of cancer.

Gender

ALL

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