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Clinical Trial Summary

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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03411408
Study type Interventional
Source Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori
Contact Oriana Nanni
Phone +390543739266
Email oriana.nanni@irst.emr.it
Status Recruiting
Phase N/A
Start date February 22, 2018
Completion date May 2024

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