Neoadjuvant Radio-chemotherapy Safety Pilot Study in Patients With Glioblastoma

Launched by HOSPITAL SAN CARLOS, MADRID · May 13, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a treatment approach called neoadjuvant radio-chemotherapy for patients with glioblastoma, a type of aggressive brain cancer. The main goals are to see how safe this treatment is and whether it helps patients live longer without their disease progressing. Participants will first have a biopsy to confirm their diagnosis, followed by a specific type of radiation therapy along with a chemotherapy drug called temozolomide. After that, they will have surgery to remove the tumor. The researchers will compare the outcomes of those receiving this new treatment with a control group who will follow the standard treatment protocol.

To be eligible for the trial, participants should be between 18 and 75 years old, have a single tumor in one area of the brain, and be able to undergo surgery without complications. It's important for potential participants to know that they will need to commit to follow-ups for two years and that they cannot have other significant health issues that would make surgery unsafe. This study is currently recruiting, and all genders are welcome to participate. By taking part, individuals may help researchers learn more about improving treatment options for glioblastoma.

Gender

ALL

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/CTFG/2020_09_HMA_CTFG_Contraception_guidance_Version_1.1.pdf)
• • Hypersensitivity to the active ingredient or any excipients of the investigational drug.