Glioblastoma Clinical Trial
— GLINERAOfficial title:
Neoadjuvant Radio-chemotherapy Safety Pilot Study in Patients With Glioblastoma
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.
Status | Recruiting |
Enrollment | 12 |
Est. completion date | March 21, 2027 |
Est. primary completion date | November 21, 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility | 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/CTFG /2020_09_HMA_CTFG_Contraception_guidance_Version_1.1.pdf) - Hypersensitivity to the active ingredient or any excipients of the investigational drug. |
Country | Name | City | State |
---|---|---|---|
Spain | Hospital Clínico San Carlos | Madrid |
Lead Sponsor | Collaborator |
---|---|
Hospital San Carlos, Madrid | Asociación de Afectados Por Tumores Cerebrales en España (ASATE) |
Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Emergent Adverse Events assessed by physical and neurological examination | Information on adverse events will be reviewed through direct questioning of the patient. | Clinical follow-up every month for 2 years | |
Primary | Emergent Adverse Events assessed by evaluation of the results of the analysis with hematology and biochemistry. | Information on adverse events will be reviewed through the results of examinations, complementary tests and analytical parameters. | Clinical follow-up every month for 2 years | |
Primary | Emergent Adverse Events assessed by brain RM image | brain RM image, for neuroradiological follow-up | every 3 months after surgery, for 2 years | |
Primary | Emergent Adverse Events assessed by AC_PET with 18-FdG | AC_PET image, for neuroradiological follow-up | every 6 months after surgery, for 2 years | |
Secondary | Efficacy assessed by progression-free survival (PFS) | Progression-free survival (PFS), a measure of how long a patient receives treatment before the cancer begins to grow. | through study completion, an average of 2 yeas. | |
Secondary | Efficacy assessed by overall survival (OS) | Overall survival (OS), how long patients live after starting treatment. | through study completion, an average of 2 yeas. | |
Secondary | Quality of life assessed by The Functional Assessment of Cancer Therapy-Brain (FACT-Br) | A commonly used instrument measuring general quality of life (QOL) that reflects symptoms or problems associated with brain malignancies across 5 scales. Patients rate all 5 items using a five-point Likert scale ranging from 0 "not at all" to 4 "very much." Overall, higher ratings suggest higher QOL | every 3 months after surgery, for 2 years | |
Secondary | Cognitive functionality assessed by MONTREAL COGNITIVE ASSESSMENT (MOCA) | It has been shown to be useful at detecting cognitive dysfunction in brain metastases.
The test is a one-page, 30-point test that can be administered in 10 minutes. It assesses short-term memory recall (5 points), visuospatial abilities through clock-drawing (3 points) and cube copy (1 point), and orientation (6 points). Executive function is assessed through modified Trail Making Part B (1 point), phonemic fluency (1 point), and verbal abstraction (2 points). A sustained-attention task (1 point), digit span (2 points), and serial calculation (3 points) test attention, concentration, and working memory. And lastly, language is assessed through naming low-familiarity animals (3 points), sentence repetition (2 points), and the fluency task |
every 3 months after surgery, for 2 years |
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