Accelerated Hypofractionated Intensity - Modulated Radiotherapy After Hyperbaric Oxygenation for Recurrent High Grade Glioma. (HBO-RT)

• ClinicalTrials.gov Identifier: NCT03411408
• Recruitment Status: Unknown
• First Posted: January 26, 2018
• Last Update Posted: April 21, 2020
• Sponsor: Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori
• Information provided by (Responsible Party): Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Malignant Glioma; High Grade Glioma; Recurrent Glioma	Device: HBO; Radiation: RT	Not Applicable

Detailed 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

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 24 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Accelerated Hypofractionated Intensity - Modulated Radiotherapy After Hyperbaric Oxygenation for Recurrent High Grade Glioma: a Pilot Study
• Actual Study Start Date: February 22, 2018
• Estimated Primary Completion Date: January 2021
• Estimated Study Completion Date: January 2021

Arms and Interventions

Arm

Intervention/treatment

Experimental: HBO and RT; Hyperbaric oxygenation therapy and Accelerated Hypofractionated intensity - modulated radiotherapy

Device: HBO; 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.; Radiation: RT; tomotherapy (within 60 minutes from completion of decompression of hyperbaric chamber) with 3-5 consecutive sessions- one fraction per day, 5 Gy / die .

Outcome Measures

Primary Outcome Measures :

1. Disease control rate (DCR) [ Time Frame: up to one year ]
   DCR will be evaluated by performing MRI images The treatment response will be evaluated according to the RANO criteria

Secondary Outcome Measures :

1. Incidence of adverse events [ Time Frame: up to 36 months ]
   Adverse events will be graded according to the National Cancer Institute Common Terminology Criteria Events v. 4.03.
2. Overall survival (OS) [ Time Frame: up to 36 months ]
   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
3. Progression Free survival (PFS) [ Time Frame: up to 36 months ]
   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.
4. Predictive score of disease progression by DSC MRI [ Time Frame: up to 36 months ]
   determining a predictive score of disease, using perfusion dynamic contrast-enhanced (DSC) permeability MRI
5. Radionecrosis by DSC MRI [ Time Frame: up to 36 months ]
   determining radionecrosis using perfusion dynamic contrast-enhanced (DSC) permeability MRI
6. Pseudoprogression by DSC MRI [ Time Frame: up to 36 months ]
   determining pseudoprogression using perfusion dynamic contrast-enhanced (DSC) permeability MRI
7. Predictive score of disease progression by DCE MRI [ Time Frame: up to 36 months ]
   determining a predictive score of disease using dynamic susceptibility contrast (DCE) perfusion MRI
8. Radionecrosis by DCE MRI [ Time Frame: up to 36 months ]
   determining radionecrosis using dynamic susceptibility contrast (DCE) perfusion MRI
9. pseudoprogression by DCE MRI [ Time Frame: up to 36 months ]
   determining pseudoprogression using dynamic susceptibility contrast (DCE) perfusion MRI

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

1. Male or Female, aged >18 years.
2. Karnofsky Performance Scale (KPS)> 60
3. Imaging confirmation of first tumor progression o regrowth as defined by Response Assessment in Neuro-Oncology Criteria (RANO) criteria at least 12 weeks after completion of radiotherapy, unless the recurrence is outside the radiation field or has been histologically documented
4. Recurrence after adjuvant treatment( surgery followed by radiotherapy and chemotherapy) in patients who could receive further therapeutic interventions
5. No more than one prior line of chemotherapy (one line of chemotherapy after concurrent and adjuvant Temozolomide (TMZ) - based chemotherapy or procarbazine/lomustine/vincristine (PCV) - Radiotherapy (RT)
6. Patients who have undergone recent surgery for recurrent o progressive high grade gliomas are eligible provided that : surgery must have confirmed the recurrence ; a minimum of 28 days must have elapsed from the days of surgery to study . For core or needle biopsy a minimum of 7 days must have elapsed prior to study .
7. If female and of child bearing potential , have a negative result on a pregnancy test performed a maximum of 7 days before initiation .
8. Female participants of child bearing potential and male participants whose partner is of child bearing potential must be willing to ensure that they or their partner use effective contraception during the study and for 4 months thereafter
9. Have adequate bone marrow function , liver function , and renal function , as measured by following laboratory assessments conducted within 7 days prior to the initiation of study treatment .
10. Hemoglobin >9.0 g/dl
11. Absolute neutrophil count (ANC) >1500/mm3 without transfusions or granulocyte colony stimulating factor and other hematopoietic growth factors
12. Platelet count ≥90,000/μl
13. White Blood Cell (WBC) >3.0 x 109/L
14. Total bilirubin <1.5 times the upper limit of normal
15. Serum creatinine <1.5 x upper limit of normal
16. Participant is willing and able to give informed consent for participation in the study.

Exclusion Criteria:

1. Radiotherapy within 12 weeks prior to the diagnosis of progression, if the lesion is in the radiation field.
2. Patients with cardiopulmonary diseases (heart failure, bolus emphysema, pneumothorax, chronic obstructive pulmonary disease (COPD) with hypercapnia sinusitis )
3. Closed angle-glaucoma with pressure ocular superior to 24 mmHg

Contacts and Locations

Contacts

Contact: Oriana Nanni; +390543739266; oriana.nanni@irst.emr.it

Locations

Italy

Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST); Recruiting

Meldola, FC, Italy, 47014

Contact: Donatella Arpa, MD donatella.arpa@irst.emr.it

Centro Iperbarico; Recruiting

Ravenna, RA, Italy, 48121

Contact: Pasquale Longobardi, MD

Neuroradiology, AUSL della Romagna - RAVENNA; Recruiting

Ravenna, RA, Italy, 48121

Contact: Patrizia Cenni

Sponsors and Collaborators

Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori

Investigators

• Principal Investigator: Donatella Arpa; IRST IRCCS

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori
• ClinicalTrials.gov Identifier: NCT03411408
• Other Study ID Numbers: IRST191.02
• First Posted: January 26, 2018
• Last Update Posted: April 21, 2020
• Last Verified: April 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori:

Hypofractionated radiotherapy; image - guided helical tomotherapy; hyperbaric oxygen therapy; malignant glioma; high grade glioma; recurrent glioma

Additional relevant MeSH terms:

Glioma; Recurrence; Disease Attributes; Pathologic Processes; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue