Neoadjuvant Radio-chemotherapy Safety Pilot Study in Patients With Glioblastoma

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

Study 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.

Eligibility

Primary outcome measure(s)

• Emergent Adverse Events assessed by physical and neurological examination — Clinical follow-up every month for 2 years
  Information on adverse events will be reviewed through direct questioning of the patient.
• Emergent Adverse Events assessed by evaluation of the results of the analysis with hematology and biochemistry. — Clinical follow-up every month for 2 years
  Information on adverse events will be reviewed through the results of examinations, complementary tests and analytical parameters.
• Emergent Adverse Events assessed by brain RM image — every 3 months after surgery, for 2 years
  brain RM image, for neuroradiological follow-up
• Emergent Adverse Events assessed by AC_PET with 18-FdG — every 6 months after surgery, for 2 years
  AC\_PET image, for neuroradiological follow-up

Trial sites (1)

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