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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.
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HBO and RT | Experimental | Hyperbaric oxygenation therapy and Accelerated Hypofractionated intensity - modulated radiotherapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HBO | Device | Hyperbaric oxygen is administrated in a multiplace hyperbaric chamber according to the following schedule: Ten minutes of compression with a Fraction of inspired oxygen (FiO2) more than 90% from 152 to 253 kilopascal, 60 minutes of Fraction of inspired oxygen (FiO2) more than 90% at 253 kilopascal (three breathing cycles in oxygen for 22 minutes each, with two intervals breathing air for 2 minutes each) and 10 minutes of decompression with a Fraction of inspired oxygen (FiO2) more than 90% from 253 to 152 kilopascal. |
| Measure | Description | Time Frame |
|---|---|---|
| Disease control rate (DCR) | DCR will be evaluated by performing MRI images The treatment response will be evaluated according to the RANO criteria | up to one year |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of adverse events | Adverse events will be graded according to the National Cancer Institute Common Terminology Criteria Events v. 4.03. | up to 36 months |
| Overall survival (OS) | OS will be defined as the time from the first day of treatment to death due any cause or censored at date last known alive |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Oriana Nanni | Contact | +390543739266 | oriana.nanni@irst.emr.it |
| Name | Affiliation | Role |
|---|---|---|
| Donatella Arpa | IRST IRCCS | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) | Recruiting | Meldola | FC | 47014 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33859944 | Derived | Arpa D, Parisi E, Ghigi G, Cortesi A, Longobardi P, Cenni P, Pieri M, Tontini L, Neri E, Micheletti S, Ghetti F, Monti M, Foca F, Tesei A, Arienti C, Sarnelli A, Martinelli G, Romeo A. Role of Hyperbaric Oxygenation Plus Hypofractionated Stereotactic Radiotherapy in Recurrent High-Grade Glioma. Front Oncol. 2021 Mar 30;11:643469. doi: 10.3389/fonc.2021.643469. eCollection 2021. |
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|
| RT | Radiation | tomotherapy (within 60 minutes from completion of decompression of hyperbaric chamber) with 3-5 consecutive sessions- one fraction per day, 5 Gy / die . |
|
| up to 36 months |
| Progression Free survival (PFS) | PFS will be calculated as the time from the first day of treatment to the date of the first observation of documented disease progression or death due to any cause. Patients without tumor progression at the time of analysis will be censored at their last date of tumor evaluation. | up to 36 months |
| Predictive score of disease progression by DSC MRI | determining a predictive score of disease, using perfusion dynamic contrast-enhanced (DSC) permeability MRI | up to 36 months |
| Radionecrosis by DSC MRI | determining radionecrosis using perfusion dynamic contrast-enhanced (DSC) permeability MRI | up to 36 months |
| Pseudoprogression by DSC MRI | determining pseudoprogression using perfusion dynamic contrast-enhanced (DSC) permeability MRI | up to 36 months |
| Predictive score of disease progression by DCE MRI | determining a predictive score of disease using dynamic susceptibility contrast (DCE) perfusion MRI | up to 36 months |
| Radionecrosis by DCE MRI | determining radionecrosis using dynamic susceptibility contrast (DCE) perfusion MRI | up to 36 months |
| pseudoprogression by DCE MRI | determining pseudoprogression using dynamic susceptibility contrast (DCE) perfusion MRI | up to 36 months |
| Centro Iperbarico | Recruiting | Ravenna | RA | 48121 | Italy |
|
| Neuroradiology, AUSL della Romagna - RAVENNA | Recruiting | Ravenna | RA | 48121 | Italy |
|
| ID | Term |
|---|---|
| D005910 | Glioma |
| ID | Term |
|---|---|
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |
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