Accelerated Hypofractionated Intensity – Modulated Radiotherapy After Hyperbaric Oxygenation for Recurrent High Grade Glioma: a Pilot Study
Description:
This is a pilot study to evaluate the efficacy of hypofractionated image- guided helical
tomotherapy after hyperbaric oxygen therapy (HBO) for treatment of recurrent malignant high –
grade gliomas The primary objective of this study is to evaluate the disease control rate
(DCR) of treated patients.
The secondary Objectives are:
– Safety assessment (acute and late toxicity).
– Overall Survival (OS),
– Progression Free Survival (PFS).
– Evaluation of predictive score of disease, radionecrosis and pseudoprogression using
perfusion DSC and DCE MRI
Patients will receive fractionated stereotactic radiotherapy using tomotherapy combined with
hyperbaric oxygen (HBO) therapy.
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 overall duration of treatment will be max 5 days.
Condition:
Malignant Glioma
Treatment:
HBO
Start Date:
February 22, 2018
Sponsor:
Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori
For More Information:
https://clinicaltrials.gov/show/NCT03411408