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

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-79
SponsorMemorial Sloan Kettering Cancer Center

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 volunteers

Qualifiers

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

Design model

Single group

Treatments tested in this trial

  • Intensity-Modulated Pleural Radiation Therapy (IMPRINT)

    Radiation

    Radiation 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

36 Participants
are divided into 1 treatment group
Group A: Hemithoracic Intensity-Modulated Pleural Radiation Therapy (IMPRINT)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
2 years

Secondary outcomes

1

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.

Time frame
12 month

Other outcomes

Sponsors and contacts

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