20
Participants
Start Date
December 9, 2022
Primary Completion Date
November 9, 2027
Study Completion Date
March 9, 2028
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);"
RECRUITING
Meyer Children's Hospital IRCCS, Florence
Iacopo Sardi
OTHER