Trial Radar AI | ||
|---|---|---|
Clinical Trial NCT05653622 (SIB-DOPA) for Glioblastoma Multiforme, Adult is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
One study matched filter criteria
Card View
Simultaneous Integrated Boost FDOPA Positron Emission Tomography (PET) Guided in Patients With Partially- or Non-operated Glioblastoma (SIB-DOPA) Phase 2 75 Overall Survival
Clinical Trial NCT05653622 (SIB-DOPA) is designed to study Treatment for Glioblastoma Multiforme, Adult. It is a Phase 2 interventional study that is recruiting, having started on 23 June 2025, with plans to enroll 75 participants. Led by Centre Paul Strauss, it is expected to complete by 1 July 2029. The latest data from ClinicalTrials.gov was last updated on 4 February 2026.
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...
Show MoreOfficial Title
Simultaneous Integrated Boost FDOPA PET Guided in Patients With Partially- or Non-operated Glioblastoma
Conditions
Glioblastoma Multiforme, AdultPublications
Scientific articles and research papers published about this clinical trial:Other Study IDs
- SIB-DOPA
- 2021-010
NCT ID Number
Start Date (Actual)
2025-06-23
Last Update Posted
2026-02-04
Completion Date (Estimated)
2029-07-01
Enrollment (Estimated)
75
Study Type
Interventional
PHASE
Phase 2
Status
Recruiting
Keywords
glioblastoma
intensity modulated radiation therapy
18F-DOPA-PET imaging
intensity modulated radiation therapy
18F-DOPA-PET imaging
Primary Purpose
Treatment
Design Allocation
N/A
Interventional Model
Single Group
Masking
None (Open Label)
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
ExperimentalSIB-DOPA | Integrated boost technique (SIB) guided by PET FDOPA intensity-modulated irradiation scheme with integrated boost technique (SIB) guided by PET FDOPA during the chemo-radiotherapy |
Primary Outcome Measures
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Overall Survival (OS) | Evaluate the overall survival (OS) of patients with glioblastoma treated with integrated boost (SIB) with increased dose guided by FDOPA PET | At 24 months after inclusion |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Progression-Free Survival (PFS) | To assess the progression-free survival (PFS) of patients with glioblastoma treated with SIB with increased dose guided by FDOPA PET | At 24 months after inclusion |
Sites of progression: distant, marginal or in-field progression | The progression will be defined by its location by comparing the progression imaging with that used for dosimetry. It will be considered "distant" if it develops beyond the 95% isodose, "marginal" if it cuts the 95% isodose and "in-field" if it is completely within the 95% isodose. The 95% isodose is the reference isodose for the prescription of hypofractionated radiotherapy. | At the date of progression, assessed up to 24 months |
Assess the rate of acute complications of grade ≥ 3 | Acute toxicities are defined as toxicities by the Common Terminology Criteria for Adverse Events (CTCAE v5) occurring within 6 months of the start of radiotherapy. | At 6 months after the start of radiotherapy |
Characterize the PET parameters during progression | PET Parameters:
* Standardized Uptake Value (SUV) max tumor, SUV max tumor/healthy tissue, SUV max T/striatum
* SUV mean tumor, SUV mean tumor/healthy tissue, SUV mean T/striatum | At the date of progression, assessed up to 24 months |
Evolution of the PET parameters | PET Parameters:
* Standardized Uptake Value (SUV) max tumor, SUV max tumor/healthy tissue, SUV max T/striatum
* SUV mean tumor, SUV mean tumor/healthy tissue, SUV mean T/striatum | Change between baseline and the date of progression, assessed up to 24 months |
Assess quality of life measured with Quality of Life Questionnaire-Cancer 30items (QLQ-C30) | The quality of life will be measured at the inclusion with Quality of Life Questionnaire-C30 (Cancer 30items).
All items are scored 1 (worse outcome) to 4 (better outcome) or 1 (worse outcome) to 7 (better outcome). All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level. | At inclusion |
Assess quality of life measured with Quality of Life Questionnaire-Brain Neoplasms 20items (QLQ-BN20) | The quality of life will be measured at the inclusion with Quality of Life Questionnaire - BN20 (Brain Neoplasms 20items).
All items are scored 1 (worse outcome) to 4 (better outcome). All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level. | At inclusion |
Assess quality of life measured with Quality of Life Questionnaire-Cancer 30items (QLQ-C30) | The quality of life will be measured at 3 months with Quality of Life Questionnaire-C30 (Cancer 30items).
All items are scored 1 (worse outcome) to 4 (better outcome) or 1 (worse outcome) to 7 (better outcome). All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level. | At 3 months after inclusion |
Assess quality of life measured with Quality of Life Questionnaire-Brain Neoplasms 20items (QLQ-BN20) | The quality of life will be measured at 3 months with Quality of Life Questionnaire - BN20 (Brain Neoplasms 20items).
All items are scored 1 (worse outcome) to 4 (better outcome). All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level. | At 3 months after inclusion |
Assess quality of life measured with Quality of Life Questionnaire-Cancer 30items (QLQ-C30) | The quality of life will be measured at 6 months with Quality of Life Questionnaire-C30 (Cancer 30items).
All items are scored 1 (worse outcome) to 4 (better outcome) or 1 (worse outcome) to 7 (better outcome). All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level. | At 6 months after inclusion |
Assess quality of life measured with Quality of Life Questionnaire-Brain Neoplasms 20items (QLQ-BN20) | The quality of life will be measured at 6 months with Quality of Life Questionnaire - BN20 (Brain Neoplasms 20items).
All items are scored 1 (worse outcome) to 4 (better outcome). All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level. | At 6 months after inclusion |
Assess quality of life measured with Quality of Life Questionnaire-Cancer 30items (QLQ-C30) | The quality of life will be measured at 12 months with Quality of Life Questionnaire-C30 (Cancer 30items).
All items are scored 1 (worse outcome) to 4 (better outcome) or 1 (worse outcome) to 7 (better outcome). All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level. | At 12 months after inclusion |
Assess quality of life measured with Quality of Life Questionnaire-Brain Neoplasms 20items (QLQ-BN20) | The quality of life will be measured at 12 months with Quality of Life Questionnaire - BN20 (Brain Neoplasms 20items).
All items are scored 1 (worse outcome) to 4 (better outcome). All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level. | At 12 months after inclusion |
Assess quality of life measured with Quality of Life Questionnaire-Cancer 30items (QLQ-C30) | The quality of life will be measured at 18 months with Quality of Life Questionnaire-C30 (Cancer 30items).
All items are scored 1 (worse outcome) to 4 (better outcome) or 1 (worse outcome) to 7 (better outcome). All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level. | At 18 months after inclusion |
Assess quality of life measured with Quality of Life Questionnaire-Brain Neoplasms 20items (QLQ-BN20) | The quality of life will be measured at 18 months with Quality of Life Questionnaire - BN20 (Brain Neoplasms 20items).
All items are scored 1 (worse outcome) to 4 (better outcome). All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level. | At 18 months after inclusion |
Correlate O6-Methylguanine-DNA Methyltransferase (MGMT) promoter methylation status and Overall survival | MGMT promoter methylation status (binary variable, determined by either Polymerase Chain reaction (PCR) or immunohistochemistry) | At 24 months after inclusion |
Correlate O6-Methylguanine-DNA Methyltransferase (MGMT) promoter methylation status and Progression-Free Survival | MGMT promoter methylation status (binary variable, determined by either PCR or immunohistochemistry) | At 24 months after inclusion |
Correlate O6-Methylguanine-DNA Methyltransferase (MGMT) promoter methylation status and acute toxicities | MGMT promoter methylation status (binary variable, determined by either PCR or immunohistochemistry) | At 24 months after inclusion |
Participation Assistant
Eligibility Criteria
Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
- Unfit patient without indication to the STUPP protocol :
Cohort 1 : Non-operable patients and ≥ 18 years old or ≤ 70 years old and Karnofsky Index (KI) ≥ 50% on inclusion AND Result of a biopsy available Cohort 2 : Patients > 70 years old and Balducci score I or II and KI ≥ 60% on inclusion AND Partial resection (defined on the remnographic criteria of postoperative MRI) OR biopsy result available
- Histologically proven glioblastoma
- Increased metabolism of amino acids in PET FDOPA allowing contouring the Biological Target Volume (BTV)
- Patients with an indication for irradiation according to the STUPP protocol (fit patient)
- Patient with a contraindication to MRI or PET
- Limit of the provisional target volume or Planning target volume (PTV), second PTV < 2 cm from the chiasm and the optic nerves
- Absence of uptake of FDopa
Centre Paul StraussStudy Central Contact
Contact: Anne ANTHONY, +33(0)388252413, [email protected]
Contact: MANON VOEGELIN, +33(0)3 68 33 95 23, [email protected]
3 Study Locations in 1 Countries
De
CHRU de Nancy, Nancy, De, 5400, France
Luc TAILLANDIER, Pr, Contact, [email protected]
Luc TAILLANDIER, Pr, Principal Investigator
Recruiting
Centre Paul Strauss, Strasbourg, France
Caroline BUND, Contact, 0368766767, [email protected]
Caroline BUND, Principal Investigator
Recruiting
ICL, Vandœuvre-lès-Nancy, France
Nicolas DEMOGEOT, Contact, 03 83 59 85 74, [email protected]
Nicolas DEMOGEOT, MD, Principal Investigator
Recruiting