histologically confirmed glioblastoma according to WHO criteria (grade IV). MedDRA version: 20.0 Level: PT Classification code 10018336 Term: Glioblastoma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Product Name: Temozolomide
Product Code: [TMZ]
Pharmaceutical Form: Capsule, hard
CAS Number: 85622-93-1
Current Sponsor code: TMZ
Concentration unit: mg milligram(s)
Concentration type: up to
Concent
Sponsors
IRCCS-A.O.U. SAN MARTINO-IST
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • 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
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. 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
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Italy
Contacts
Public ContactCENTRO CLINICAL TRIALS
IRCCS OSPEDALE POLICLINICO SAN MARTINO
Outcome results
None listed