Ignite Creation Date:
2024-05-06 @ 2:22 PM
Last Modification Date:
2024-10-26 @ 1:30 PM
Study NCT ID:
NCT04304300
Status:
COMPLETED
Last Update Posted:
2020-03-25
First Post:
2020-03-09
Brief Title:
Radiotherapy in IDH Mutated Glioma Evaluation of Late Outcomes
Sponsor:
Erasmus Medical Center
Organization:
Erasmus Medical Center
Study Overview
Official Title:
Radiotherapy in IDH Mutated Glioma Evaluation of Late Outcomes
Status:
COMPLETED
Status Verified Date:
2024-10
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:
RIGEL
Brief Summary:
Rationale Standard postoperative treatment of isocitrate dehydrogenase 12 mutated grade 2 and 3 glioma IDHmG consists of radiotherapy and chemotherapy The improving prognosis of these patients leads towards more emphasis on the long-term effects of treatment Specifically radiotherapy has been implicated in the development of delayed neurocognitive deterioration The impact of modern radiotherapy techniques such as intensity modulated radiotherapy volumetric modulated radiotherapy and proton beam therapy and chemotherapy on general toxicity late neurocognitive outcomes and imaging changes is currently unclear
Objectives
To report treatment outcomes and radiation-induced toxicity from a prospective multicentre observational cohort of IDHmG patients treated with radiotherapy and chemotherapy
To integrate radiotherapeutic dose distributions imaging changes and neuropsychological outcome in IDHmG
To evaluate the Dutch selection criteria for proton therapy applied to IDHmG based on the outcomes collected in this observational study
To assess the impact of proton and photon therapy on health-related quality of life HRQoL and health-related economics HR-E in IDHmG patients
To collect genetic material for future translational research into the interaction between germline DNA prognosis and radiation-induced toxicity
Nature and extent of the burden and risks associated with participation benefit and group relatedness This project is a multicentre observational cohort of patients undergoing radiotherapy and chemotherapy for IDHmG The protocol closely follows the local guidelines for clinical follow-up Specific to the study are extra questionnaires and specific imaging acquired during scheduled MRIs Routine neuropsychological investigation is standard of care in Erasmus Medical Center Erasmus MC but not in all participating centers We feel the additional burden of participation in this study to be low
Objectives
To report treatment outcomes and radiation-induced toxicity from a prospective multicentre observational cohort of IDHmG patients treated with radiotherapy and chemotherapy
To integrate radiotherapeutic dose distributions imaging changes and neuropsychological outcome in IDHmG
To evaluate the Dutch selection criteria for proton therapy applied to IDHmG based on the outcomes collected in this observational study
To assess the impact of proton and photon therapy on health-related quality of life HRQoL and health-related economics HR-E in IDHmG patients
To collect genetic material for future translational research into the interaction between germline DNA prognosis and radiation-induced toxicity
Nature and extent of the burden and risks associated with participation benefit and group relatedness This project is a multicentre observational cohort of patients undergoing radiotherapy and chemotherapy for IDHmG The protocol closely follows the local guidelines for clinical follow-up Specific to the study are extra questionnaires and specific imaging acquired during scheduled MRIs Routine neuropsychological investigation is standard of care in Erasmus Medical Center Erasmus MC but not in all participating centers We feel the additional burden of participation in this study to be low
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| Netherlands Trial Register | REGISTRY | NL7993 | None |