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New treatment option for Thymic Malignancies
Official title 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
ClinicalTrials.gov ID: NCT05354570
What this study is testing
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 79
You may be able to join if
- 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...
- No evidence of extrathoracic metastatic disease or contralateral pleural/pericardial disease.
- Patient age ≥ 18 years but ≤ 80 years at the time of consent
You likely can't join if
- 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...
- Acute congestive heart failure requiring hospitalization within the past 30 days.
See the full eligibility 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Basking Ridge, New Jersey, United States
- Middletown, New Jersey, United States
- Montvale, New Jersey, United States
- Commack, New York, United States
- Harrison, New York, United States
- New York, New York, United States
- Rockville Centre, New York, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 79 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Basking Ridge, New Jersey, United States; Middletown, New Jersey, United States; Montvale, New Jersey, United States; Commack, New York, United States; Harrison, New York, United States; New York, New York, United States and 1 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.