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Accelerated Hypofractionated Intensity - Modulated Radiotherapy After Hyperbaric Oxygenation for Recurrent High Grade Glioma: a Pilot Study (HBO-RT)
This is a pilot study of radiotherapy using Hypofractionated image - guided helical tomotherapy after hyperbaric oxygen HBO therapy for treatment of recurrent malignant High-grade gliomas. HBO therapy will be perform in conjunction with each RT session. The treatment scheme is: Hyperbaric oxygenation therapy (the maximum period of time from completion of decompression to RT is 60 min) followed by tomotherapy (3-5 consecutive sessions- one fraction per day , 5 Gy / die ). The trial will enroll 24 patients in 24 months with a follow-up period of 1 year.
Details
| Lead sponsor | Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS |
|---|---|
| Phase | NA |
| Status | UNKNOWN |
| Enrolment | 24 |
| Start date | 2018-02-22 |
| Completion | 2024-05 |
Conditions
- Malignant Glioma
- High Grade Glioma
- Recurrent Glioma
Interventions
- HBO
- RT
Primary outcomes
- Disease control rate (DCR) — up to one year
DCR will be evaluated by performing MRI images The treatment response will be evaluated according to the RANO criteria
Countries
Italy