Ignite Creation Date:
2024-05-19 @ 5:34 PM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06418113
Status:
RECRUITING
Last Update Posted:
2024-05-16
First Post:
2024-04-03
Brief Title:
Neoadjuvant Radio-chemotherapy Safety Pilot Study in Patients With Glioblastoma
Sponsor:
Hospital San Carlos Madrid
Organization:
Hospital San Carlos Madrid
Study Overview
Official Title:
Neoadjuvant Radio-chemotherapy Safety Pilot Study in Patients With Glioblastoma
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
GLINERA
Brief 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None