Status:
UNKNOWN
Accelerated Hypofractionated Intensity - Modulated Radiotherapy After Hyperbaric Oxygenation for Recurrent High Grade Glioma.
Lead Sponsor:
Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS
Conditions:
Malignant Glioma
High Grade Glioma
Eligibility:
All Genders
18+ years
Phase:
NA
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...
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...
Eligibility Criteria
Inclusion
- 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
- Participant is willing and able to give informed consent for participation in the study.
Exclusion
- 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
Key Trial Info
Start Date :
February 22 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2024
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT03411408
Start Date
February 22 2018
End Date
May 1 2024
Last Update
May 30 2023
Active Locations (3)
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1
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST)
Meldola, FC, Italy, 47014
2
Centro Iperbarico
Ravenna, RA, Italy, 48121
3
Neuroradiology, AUSL della Romagna - RAVENNA
Ravenna, RA, Italy, 48121