Evaluate the Role of Anthracycline After Radio Therapy in Patients With Glioblastoma (pGBM).

PHASE2RecruitingINTERVENTIONAL
Enrollment

20

Participants

Timeline

Start Date

December 9, 2022

Primary Completion Date

November 9, 2027

Study Completion Date

March 9, 2028

Conditions
Glioblastoma
Interventions
DRUG

Radiotherapy, Temozolomide, Doxorubicin

"Radiation treatment Concomitant TMZ: 75mg/m2/day per OS for 7 days per week, from the first day of radiotherapy to the last (maximum cumulative dose 3150mg/m2), with possibility of earlier initiation on clinician's judgment.~After 1 month (4-5 weeks ± 7 days) from the end of RT/TMZ treatment they will receive:~Adjuvant TMZ: 2 cycles at increasing doses (150-180 mg/m2) per OS for 5 consecutive days 28 days apart~After 3 months (12 weeks ± 7 days) from the end of RT/TMZ treatment they will receive:~Dox 4 cycles with 37.5mg/m2/day by continuous infusion over 48 hours (2 days) every 28 days (maximum cumulative dose 300mg/m2)~And after 4 weeks ± 7 days from the end of Dox treatment they will receive:~TMZ adjuvant 12 cycles at increasing doses (150-180 mg/m2) by OS for 5 consecutive days 28 days apart (maximum cumulative dose 16200 mg/m2);"

Trial Locations (1)

Unknown

RECRUITING

Meyer Children's Hospital IRCCS, Florence

All Listed Sponsors
lead

Iacopo Sardi

OTHER