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Malignant GliomaHBO-RTNCT03411408

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

A study testing HBO and RT in people with Malignant Glioma and High Grade Glioma, run by Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS at 3 sites in Italy.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
HBO and RT
Could I receive a placebo?
No, everyone receives an active treatment
How many people
24 participants
Where
3 sitesItaly
Study dates
22 Feb 2018to May 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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 .
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  • 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
  • Participant is willing and able to give informed consent for participation in the study.

Who cannot join

  • 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

Trial locations and contacts

3 sites in 1 country.

Oriana Nanni contact

+390543739266

oriana.nanni@irst.emr.it

Italy3 sites, 3 recruiting

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

    Meldola, FC, 47014

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

    Recruiting

  • Centro Iperbarico

    Ravenna, RA, 48121

    Pasquale Longobardi, MD

    Recruiting

  • Neuroradiology, AUSL della Romagna - RAVENNA

    Ravenna, RA, 48121

    Patrizia Cenni

    Recruiting

Other trials in Italy

About this study

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

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.

Read the 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.

Being tested
HBO, RT
Keywords
Hypofractionated radiotherapy, image - guided helical tomotherapy, hyperbaric oxygen therapy, malignant glioma, high grade glioma, recurrent glioma
Medical subject headings
Glioma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • HBODevice

    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.

  • RTRadiation

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

Study groups in NCT03411408
Study groupRoleWhat they receive
HBO and RTExperimentalHyperbaric oxygenation therapy and Accelerated Hypofractionated intensity - modulated radiotherapy
Receives: Device: HBO; Radiation: RT

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Disease control rate (DCR)

    DCR will be evaluated by performing MRI images The treatment response will be evaluated according to the RANO criteria

    Measured: up to one year

Secondary outcomes (9)

  1. Incidence of adverse events

    Adverse events will be graded according to the National Cancer Institute Common Terminology Criteria Events v. 4.03.

    Measured: up to 36 months

  2. 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

    Measured: up to 36 months

  3. 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.

    Measured: up to 36 months

  4. Predictive score of disease progression by DSC MRI

    determining a predictive score of disease, using perfusion dynamic contrast-enhanced (DSC) permeability MRI

    Measured: up to 36 months

  5. Radionecrosis by DSC MRI

    determining radionecrosis using perfusion dynamic contrast-enhanced (DSC) permeability MRI

    Measured: up to 36 months

  6. Pseudoprogression by DSC MRI

    determining pseudoprogression using perfusion dynamic contrast-enhanced (DSC) permeability MRI

    Measured: up to 36 months

  7. Predictive score of disease progression by DCE MRI

    determining a predictive score of disease using dynamic susceptibility contrast (DCE) perfusion MRI

    Measured: up to 36 months

  8. Radionecrosis by DCE MRI

    determining radionecrosis using dynamic susceptibility contrast (DCE) perfusion MRI

    Measured: up to 36 months

  9. pseudoprogression by DCE MRI

    determining pseudoprogression using dynamic susceptibility contrast (DCE) perfusion MRI

    Measured: up to 36 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Jan 2018
  2. Study start22 Feb 2018
  3. Primary completionMay 2024 (estimated)
  4. Study completionMay 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
24 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03411408
Sponsor's protocol ID
IRST191.02
Acronym
HBO-RT
Status last verified
May 2023
First submitted
11 Jan 2018
Last updated
30 May 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 33859944

Questions about this trial

What is this clinical trial studying?

A study testing HBO and RT in people with Malignant Glioma and High Grade Glioma, run by Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS at 3 sites in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 16 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 30 May 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Oriana Nanni (+390543739266, oriana.nanni@irst.emr.it), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Disease control rate (DCR) (time frame: up to one year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03411408, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2023.

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