Trial Title:
Neoadjuvant Radio-chemotherapy Safety Pilot Study in Patients With Glioblastoma
NCT ID:
NCT06418113
Condition:
Glioblastoma
Glioblastoma Multiforme
Glioblastoma, IDH-wildtype
Radiotherapy; Complications
Cancer Brain
Conditions: Official terms:
Glioblastoma
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Radiation
Intervention name:
hypofractionated stereotactic radiotherapy
Description:
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
Arm group label:
Experimental
Intervention type:
Procedure
Intervention name:
Stereotactic biopsy
Description:
Stereotactic biopsy
Arm group label:
Experimental
Intervention type:
Procedure
Intervention name:
resection
Description:
supramarginal resection guided by 5-ALA under intraoperative neurophysiological
monitoring
Arm group label:
Experimental
Arm group label:
Stupp Protocol
Intervention type:
Drug
Intervention name:
Chemotherapy
Description:
4 weeks post-surgery, temozolomide (TMZ) will be administered for 6 months
Arm group label:
Experimental
Intervention type:
Radiation
Intervention name:
radiotherapy Stupp protocol
Description:
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.
Arm group label:
Stupp Protocol
Intervention type:
Drug
Intervention name:
Chemotherapy Stupp Protocol
Description:
temozolomide (TMZ) will be administered for 6 months according to the Stupp protocol.
Arm group label:
Stupp Protocol
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.
Detailed description:
Objectives: To study the safety (primary) and efficacy (secondary) of neoadjuvant
radiochemotherapy in the surgical resection of glioblastoma (GBM). Safety measures
include: neurological deficit, radionecrosis (radiological and clinical), edema,
headache, wound dehiscence, infection, and cerebrospinal fluid fistula. Efficacy measures
include progression-free survival (PFS), overall survival (OS), cognitive function (MoCA
Scale), and quality of life (EuroQol scales, EORTC QLQ-HN35, FACT-Br, and TWiST).
Methods: Pilot safety and efficacy study in 6 patients compared to 6 controls. 2-year
follow-up. A data safety monitoring committee will review the data one month after
surgery for each of the first three patients to decide whether to stop or continue the
study. Stereotactic biopsy will be performed, and if GBM is diagnosed, patients will
undergo 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 and concurrent temozolomide (TMZ). 5 weeks later,
patients will undergo supramarginal resection guided by 5-ALA under intraoperative
neurophysiological monitoring. 7 days after surgery, maintenance TMZ will be administered
for 6 months. The control group will follow standard treatment (Stupp protocol). Data
analysis will be performed using non-parametric tests. Samples from successive surgeries
will be studied with histology, molecular biology, and cell cultures.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Age between 18 and 75 years.
- Unifocal disease.
- Unilobar tumor.
- Clinical-radiological diagnosis of supratentorial unicentric high-grade glioma,
eligible for macroscopically complete resection.
Exclusion Criteria:
- Multilobar tumor, interhemispheric or infratentorial extension, or multifocal
disease.
- Midline shift greater than 1 cm.
- Intracranial hypertension symptoms requiring corticosteroid treatment.
- Synchronous neoplasia.
- Any contraindication for surgery, radiotherapy, or TMZ treatment.
- Cognitive impairment.
- Rejection of informed consent.
- Inability to follow up for 2 years.
- Women of childbearing potential according to the Clinical Trial Facilitation Group
(CTFG) criteria.
(https://www.hma.eu/fileadmin/dateien/Human_Medicines/01-About_HMA/Working_Groups/CT
FG/2020_09_HMA_CTFG_Contraception_guidance_Version_1.1.pdf)
- Hypersensitivity to the active ingredient or any excipients of the investigational
drug.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Hospital Clínico San Carlos
Address:
City:
Madrid
Zip:
28040
Country:
Spain
Status:
Recruiting
Contact:
Last name:
Juan Antonio Barcia
Phone:
+34 913303506
Email:
jabarcia@ucm.es
Contact backup:
Last name:
Mª Rebeca Lliguin León
Phone:
622059861
Email:
rebeca.lliguin.leon@gmail.com
Start date:
March 21, 2024
Completion date:
March 21, 2027
Lead sponsor:
Agency:
Hospital San Carlos, Madrid
Agency class:
Other
Collaborator:
Agency:
Asociación de Afectados Por Tumores Cerebrales en España (ASATE)
Agency class:
Other
Source:
Hospital San Carlos, Madrid
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06418113
