At a glance
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A Phase II Trial of Surgery and Fractionated Re-Irradiation for Recurrent Ependymoma
In Brief
A Phase 2 clinical trial evaluating Irradiation, Surgery, and 4 other interventions for Ependymoma. Active but no longer recruiting, targeting 68 participants across 1 site.
Detailed Summary
The primary purpose of this study is to investigate whether surgery and re-irradiation will help treat ependymoma that has come back after initial treatment. The combined doses of the first and second courses of radiation are higher than what is usual standard of care. The investigators will study the effects and side effects of surgery and re-irradiation. They will also evaluate and study tumor tissue and blood to learn more about the tumor and how it does or does not respond to treatments and will use magnetic resonance imaging (MRI) and positron emission tomography (PET) scans to see if they can predict tumor response and tumor recurrence. Participants will be followed for up to 5 years following enrollment. Evaluations during radiation therapy will be done weekly while receiving therapy for up to 7 weeks. Other evaluations will be done at enrollment, every 4 months from enrollment through 3 years, and every 6 months during the 4th and 5th year.
Study Details
Timeline
Interventions
Radiation therapy on this protocol will be based on extent of disease, extent of resection and location. The allowed treatment modalities include conformal or intensity-modulated radiation therapy using photons or proton therapy using double-scattering or spot-scanning methods. The general goal is to initiate radiation therapy within 12 weeks of last surgery performed at the time of recurrence.
When applicable, surgery will be used to remove metastases. The goal of surgery is to achieve gross total resection of all imaging visible residual tumor.
This is a contrast media that will be given intravenously to aid in tumor visualization.
This is a contrast media that will be given intravenously to aid in tumor visualization.
Participants will receive one or both: Photon or proton therapy.
Participants will receive one or both: Photon or proton therapy.