About this trial
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
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Single group
Treatments tested in this trial
Intensity-Modulated Pleural Radiation Therapy (IMPRINT)
RadiationRadiation therapy will be administered over approximately 6 weeks at 50.4 Gy in 28 fractions, including an optional dose-painting SIB to gross residual disease up to 60 Gy while respecting normal tissue constraints.
Treatment groups
Trial outcomes
Primary outcomes
assess the rate of radiation pneumonitis
as indicated by the rate of grade 3 or higher radiation pneumonitis defined by the NCI Common Terminology Criteria (CTC) version 5.0.
Secondary outcomes
progression-free survival (PFS)
PFS events will include death and/or progression of thymic malignancy due to local-regional or distant recurrence/progression. PFS will be calculated from the start of radiation treatment and will be estimated by the Kaplan-Meier method.
Sponsors and contacts
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