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

NCT03411408 | Unknown

• 1 other identifier: IRST191.02
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 3

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.

Conditions

Malignant Glioma; High Grade Glioma; Recurrent Glioma

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Incidence of adverse events

  up to 36 months

• Overall survival (OS)

  up to 36 months

• Progression Free survival (PFS)

  up to 36 months

• Predictive score of disease progression by DSC MRI

  up to 36 months

• Radionecrosis by DSC MRI

  up to 36 months

Study Arms (1)

HBO and RT

EXPERIMENTAL

Hyperbaric oxygenation therapy and Accelerated Hypofractionated intensity - modulated radiotherapy

Device: HBO; Radiation: RT

Interventions

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.

HBO and RT

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 .

HBO and RT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or Female, aged \>18 years.
• Karnofsky Performance Scale (KPS)\> 60
• 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
• Recurrence after adjuvant treatment( surgery followed by radiotherapy and chemotherapy) in patients who could receive further therapeutic interventions
• 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)
• 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 .
• If female and of child bearing potential , have a negative result on a pregnancy test performed a maximum of 7 days before initiation .
• 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
• 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 .
• Hemoglobin \>9.0 g/dl
• Absolute neutrophil count (ANC) \>1500/mm3 without transfusions or granulocyte colony stimulating factor and other hematopoietic growth factors
• Platelet count ≥90,000/μl
• White Blood Cell (WBC) \>3.0 x 109/L
• Total bilirubin \<1.5 times the upper limit of normal
• Serum creatinine \<1.5 x upper limit of normal

You may not qualify if:

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

Sponsors & Collaborators

• Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS: lead

Study Sites (3)

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

Meldola, FC, 47014, Italy

RECRUITING

Centro Iperbarico

Ravenna, RA, 48121, Italy

RECRUITING

Neuroradiology, AUSL della Romagna - RAVENNA

Ravenna, RA, 48121, Italy

RECRUITING

Related Publications (1)

• 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.

  PMID: 33859944 DERIVED

MeSH Terms

Conditions

Glioma

Condition Hierarchy (Ancestors)

Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Study Officials

• Donatella Arpa

  IRST IRCCS

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Oriana Nanni

CONTACT

+390543739266; oriana.nanni@irst.emr.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 11, 2018
• First Posted: January 26, 2018
• Study Start: February 22, 2018
• Primary Completion: May 1, 2024
• Study Completion: May 1, 2024
• Last Updated: May 30, 2023

Record last verified: 2023-05

Locations

IT (3)