Neoadjuvant Radio-chemotherapy Safety Pilot Study in Patients With Glioblastoma

PHASE1RecruitingINTERVENTIONAL
Enrollment

12

Participants

Timeline

Start Date

March 21, 2024

Primary Completion Date

November 21, 2026

Study Completion Date

March 21, 2027

Conditions
GlioblastomaGlioblastoma MultiformeGlioblastoma, IDH-wildtypeRadiotherapy; ComplicationsCancer Brain
Interventions
RADIATION

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

PROCEDURE

Stereotactic biopsy

Stereotactic biopsy

PROCEDURE

resection

supramarginal resection guided by 5-ALA under intraoperative neurophysiological monitoring

DRUG

Chemotherapy

4 weeks post-surgery, temozolomide (TMZ) will be administered for 6 months

RADIATION

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.

DRUG

Chemotherapy Stupp Protocol

temozolomide (TMZ) will be administered for 6 months according to the Stupp protocol.

Trial Locations (1)

28040

RECRUITING

Hospital Clínico San Carlos, Madrid

All Listed Sponsors
collaborator

Asociación de Afectados Por Tumores Cerebrales en España (ASATE)

UNKNOWN

lead

Hospital San Carlos, Madrid

OTHER