TEMOZOLOMIDE + ULTRA-HYPER-FRACTIONATED RADIOTHERAPY VS TEMOZOLOMIDE ALONE FOR THE MAINTENANCE TREATMENT OF GLIOBLASTOMA PATIENTS - PILOT STUDY - Ultra Hyper Fractionated Radiatherapy as a maintenance treatment for glioblastoma

IRCCS-A.O.U. SAN MARTINO-IST0 个研究点目标入组 30 人开始时间: 2021年10月7日最近更新: 2022年3月2日

适应症

试验速览

暂无简介。

•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.

发起方

IRCCS-A.O.U. SAN MARTINO-IST