TEMOZOLOMIDE + ULTRA-HYPER-FRACTIONATED RADIOTHERAPY VS TEMOZOLOMIDE ALONE FOR THE MAINTENANCE TREATMENT OF GLIOBLASTOMA PATIENTS - PILOT STUDY
- Conditions
- histologically confirmed glioblastoma according to WHO criteria (grade IV).MedDRA version: 20.0Level: PTClassification code 10018336Term: GlioblastomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2021-003275-34-IT
- Lead Sponsor
- IRCCS-A.O.U. SAN MARTINO-IST
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 30
•Adult patients (age =18 to =90 years).
•Patients who have undergone maximal surgical resection.
•Histologically confirmed diagnosis of GB according to WHO criteria (grade IV).
•Completed 6-week TMZ + conv-FRT treatment (Stupp protocol).
•Ability to correctly provide informed consent.
•Karnofsky performance status > 70%
•Radiation dose already received at critical areas such as optic chiasm, circle of Willis, hypothalamus, hippocampal areas, pituitary gland and cochleae sufficiently low to permit the delivery of the additional ultra-hyper-FRT dose (12.5 Gy/year).
•Willingness to follow a long-term ultra-hyper-FRT treatment.
•Ability to understand and willingness to sign a written informed consent.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 15
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 15
Exclusion Criteria
•Maximum tolerated radiation dose received at critical areas such as optic chiasm, circle of Willis, hypothalamus, hippocampal areas, pituitary gland and cochleae.
•Pregnant and lactating women.
•Pre-menopausal women of child-bearing potential and male with fertile partner who are not willing to employ effective contraception according to 2007 clinical trial facilitation group (CTFG) Recommendations related to contraception and pregnancy testing in clinical trials” from screening for all the duration of the study.
•Any psychiatric, social or compliance issues that, in the treating physician opinion, will interfere with completion of the ultra-hyper-FRT treatment.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To compare the effect on overall survival (OS) of the maintenance treatment with TMZ + ultra-hyper-FRT vs TMZ alone in GB patients;Secondary Objective: To compare the effect on progression free survival (PFS) of the maintenance treatment with TMZ + ultra-hyper-FRT vs TMZ alone in GB patients.<br>To evaluate early/late toxicities/complications by organ/severity.;Primary end point(s): Overall survival defined as the time from the date of randomization to the date of death from any cause.;Timepoint(s) of evaluation of this end point: 24 months
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Progression-free survival (PFS) defined as the time between the date of randomization and the date of the first documented occurrence of disease progression or the date of death, whichever comes first.;Timepoint(s) of evaluation of this end point: 24 months