A Study of Intensity-Modulated Pleural Radiation Therapy (IMPRINT) in People With Thymic Cancer T… (NCT05354570) | Clinical Trial Compass
RecruitingPhase 2
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
United States36 participantsStarted 2022-04-26
Plain-language 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.
Who can participate
Age range18 Years – 79 Years
SexALL
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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 metas…