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

Study Purpose

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.

Recruitment Criteria

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Accepts Healthy Volunteers
No

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An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


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Study Type
Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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

Trial Details

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

Trial ID:
NCT03411408

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase
N/A

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

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

The person who is responsible for the scientific and technical direction of the entire clinical study.

Principal Investigator
Donatella Arpa
Principal Investigator Affiliation IRST IRCCS

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Agency Class
Other
Overall Status Recruiting
Countries Italy

The disease, disorder, syndrome, illness, or injury that is being studied.

Conditions
Malignant Glioma, High Grade Glioma, Recurrent Glioma
Additional Details

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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Ravenna, RA, Italy

Status

Recruiting

Address

Neuroradiology, AUSL della Romagna - RAVENNA

Ravenna, RA, 48121

Site Contact

Patrizia Cenni

oriana.nanni@irst.emr.it

+390543739266

Centro Iperbarico, Ravenna, RA, Italy

Status

Recruiting

Address

Centro Iperbarico

Ravenna, RA, 48121

Site Contact

Pasquale Longobardi, MD

oriana.nanni@irst.emr.it

+390543739266

Meldola, FC, Italy

Status

Recruiting

Address

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

Meldola, FC, 47014

Site Contact

Donatella Arpa, MD

donatella.arpa@irst.emr.it

+390543739266

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