Neoadjuvant Radio-chemotherapy Safety Pilot Study in Patients With Glioblastoma

Summary

The goal of this clinical trial is to evaluate the safety and efficacy of neoadjuvant radiochemotherapy in the surgical resection of glioblastoma (GBM). The main questions it aims to answer are:

* What is the safety profile of neoadjuvant radiochemotherapy in terms of neurological deficit, radionecrosis, edema, headache, wound dehiscence, infection, and cerebrospinal fluid fistula?
* What is the efficacy of neoadjuvant radiochemotherapy in terms of progression-free survival, overall survival, cognitive function, and quality of life?

Participants will undergo the following tasks and treatments:

* Stereotactic biopsy and diagnosis confirmation.
* Conformal hypofractionated stereotactic radiotherapy with concurrent temozolomide.
* Supramarginal resection guided by 5-ALA under intraoperative neurophysiological monitoring.
* Maintenance temozolomide administration for 6 months.

Researchers will compare the group receiving neoadjuvant radiochemotherapy to the control group following the standard Stupp protocol to assess safety and efficacy outcomes.

Conditions

• Glioblastoma
• Glioblastoma Multiforme
• Glioblastoma, IDH-wildtype
• Radiotherapy; Complications
• Cancer 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.

Sponsors & Collaborators

• Asociación de Afectados Por Tumores Cerebrales en España (ASATE)

  collaborator UNKNOWN

• Hospital San Carlos, Madrid

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-03-21

Primary Completion

2026-11-21

Completion

2027-03-21

Countries

• Spain

Study Locations