Ignite Creation Date:
2024-05-06 @ 6:24 PM
Last Modification Date:
2024-10-26 @ 2:47 PM
Study NCT ID:
NCT05653622
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-03-06
First Post:
2022-11-28
Brief Title:
Simultaneous Integrated Boost FDOPA Positron Emission Tomography PET Guided in Patients With Partially- or Non-operated Glioblastoma
Sponsor:
Institut de cancérologie Strasbourg Europe
Organization:
Institut de cancérologie Strasbourg Europe
Study Overview
Official Title:
Simultaneous Integrated Boost FDOPA PET Guided in Patients With Partially- or Non-operated Glioblastoma
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-03
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:
SIB-DOPA
Brief Summary:
Glioblastoma GBM is the most common primary brain cancer in adults Surgery chemoradiotherapy temozolomide TMZ and then adjuvant TMZ is the standard treatment But most patients relapse in a median time of 8-9 months the median overall survival OS ranged from 15 to 18 months
Some frail patients received hypofractionated radiation and concomitant and adjuvant TMZ For some the radiation dose is not optimal Moreover recurrences develop mainly in the initial tumor site These two reasons justify increasing the dose To limit the movements of these fragile patients the method consists of increasing the dose without increasing the number of sessions by using the Simultaneous Integrated Boost SIB which increases the dose in targeted volumes while the rest of the volume receives a minimum dose A phase I trial showed the possibility of increasing the dose in SIB up to 80 Gy in a part of the GBM enhanced on MRI
FDOPA PET detects certain more aggressive tumor areas areas likely to recur Integrating them into the SIB seems appropriate A phase II trial showed the interest of SIB guided by FDOPA PET in terms of progression-free survival but without impact on OS This study differed from the one the investigators propose because a dose and conventional fractionation identical to that of the European Organization for Research and Treatment of CancerNational Cancer Information Center NCICEORTC protocol were delivered the gliomas were unmethylated MGMT less likely to respond Studies with SIB and hypofractionation are often retrospective and for others hypofractionation was debatable and the dose increase was not based on PET capture but on MRI However a prospective phase II study with SIB and hypofractionation not integrating FDopa PET has demonstrated the relevance of SIB
In this project the investigators propose to use the integrated boost technique SIB guided by PET FDOPA to increase the radiation dose in GBM in patients either fragile and partially operated or only biopsied and for whom the prognosis is the most pejorative
Some frail patients received hypofractionated radiation and concomitant and adjuvant TMZ For some the radiation dose is not optimal Moreover recurrences develop mainly in the initial tumor site These two reasons justify increasing the dose To limit the movements of these fragile patients the method consists of increasing the dose without increasing the number of sessions by using the Simultaneous Integrated Boost SIB which increases the dose in targeted volumes while the rest of the volume receives a minimum dose A phase I trial showed the possibility of increasing the dose in SIB up to 80 Gy in a part of the GBM enhanced on MRI
FDOPA PET detects certain more aggressive tumor areas areas likely to recur Integrating them into the SIB seems appropriate A phase II trial showed the interest of SIB guided by FDOPA PET in terms of progression-free survival but without impact on OS This study differed from the one the investigators propose because a dose and conventional fractionation identical to that of the European Organization for Research and Treatment of CancerNational Cancer Information Center NCICEORTC protocol were delivered the gliomas were unmethylated MGMT less likely to respond Studies with SIB and hypofractionation are often retrospective and for others hypofractionation was debatable and the dose increase was not based on PET capture but on MRI However a prospective phase II study with SIB and hypofractionation not integrating FDopa PET has demonstrated the relevance of SIB
In this project the investigators propose to use the integrated boost technique SIB guided by PET FDOPA to increase the radiation dose in GBM in patients either fragile and partially operated or only biopsied and for whom the prognosis is the most pejorative
Detailed Description:
None
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