Accelerated Hypofractionated Intensity - Modulated Radiotherapy After Hyperbaric Oxygenation for Recurrent High Grade Glioma.

Malignant Glioma Clinical Trial

— HBO-RT  

Official title:

Accelerated Hypofractionated Intensity - Modulated Radiotherapy After Hyperbaric Oxygenation for Recurrent High Grade Glioma: a Pilot Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03411408
• Other study ID #: IRST191.02
• Status: Recruiting
• Phase: N/A
• Start date: February 22, 2018
• Est. completion date: May 2024

Study information

• Verified date: May 2023
• Source: Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori
• Contact: Oriana Nanni
• Phone: +390543739266
• Email: oriana.nanni[@]irst.emr.it
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 24
• Est. completion date: May 2024
• Est. primary completion date: May 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Glioma
• High Grade Glioma
• Malignant Glioma
• Recurrence
• Recurrent Glioma

Intervention

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 .

Locations

Country	Name	City	State
Italy	Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST)	Meldola	FC
Italy	Centro Iperbarico	Ravenna	RA
Italy	Neuroradiology, AUSL della Romagna - RAVENNA	Ravenna	RA

Sponsors (1)

Lead Sponsor	Collaborator
Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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
Secondary	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	up to 36 months
Secondary	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
Secondary	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
Secondary	Radionecrosis by DSC MRI	determining radionecrosis using perfusion dynamic contrast-enhanced (DSC) permeability MRI	up to 36 months
Secondary	Pseudoprogression by DSC MRI	determining pseudoprogression using perfusion dynamic contrast-enhanced (DSC) permeability MRI	up to 36 months
Secondary	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
Secondary	Radionecrosis by DCE MRI	determining radionecrosis using dynamic susceptibility contrast (DCE) perfusion MRI	up to 36 months
Secondary	pseudoprogression by DCE MRI	determining pseudoprogression using dynamic susceptibility contrast (DCE) perfusion MRI	up to 36 months