12
Participants
Start Date
March 21, 2024
Primary Completion Date
November 21, 2026
Study Completion Date
March 21, 2027
hypofractionated stereotactic radiotherapy
conformal hypofractionated stereotactic radiotherapy to the FLAIR hyperintense signal, including the contrast-enhancing tumor on T1, with a total dose of 3990 cGy at the margin in 15 fractions of 266 cGy, one session per day, five days a week, and concurrent temozolomide (TMZ) at 75 mg/m2/day for 7 days/week during the irradiation period
Stereotactic biopsy
Stereotactic biopsy
resection
supramarginal resection guided by 5-ALA under intraoperative neurophysiological monitoring
Chemotherapy
4 weeks post-surgery, temozolomide (TMZ) will be administered for 6 months
radiotherapy Stupp protocol
radiotherapy + TMZ concurrently after 4 weeks of resection surgery, as per usual protocol: Three-dimensional radiotherapy planning to deliver a total dose of 60 Gy, with a fractionation of 2 Gy/day, 5 days/week, encompassing a 1-2 cm margin around the contrast-enhancing region defined on T1 imaging or the entire abnormal volume defined on T2 or FLAIR imaging (Li et al., 2016) + TMZ at 75 mg/m2/day for 7 days/week, for 6 weeks during radiotherapy.
Chemotherapy Stupp Protocol
temozolomide (TMZ) will be administered for 6 months according to the Stupp protocol.
RECRUITING
Hospital Clínico San Carlos, Madrid
Asociación de Afectados Por Tumores Cerebrales en España (ASATE)
UNKNOWN
Hospital San Carlos, Madrid
OTHER