Contribution From PET-DOPA in Glioblastoma Re-irradiation - A Randomized Phase II Study
NCT ID: NCT05653635
Last Updated: 2023-03-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE2
54 participants
INTERVENTIONAL
2023-09-01
2028-09-01
Brief Summary
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Detailed Description
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In case of recurrence, a second surgery, radiotherapy under stereotaxic conditions, bevacizumab or other innovative techniques have been proposed. However, they are not yet considered as reference treatments, due to the absence of therapeutic trials definitively proving their efficacy.
Evaluation of GBM progression is based on MRI, corticosteroid intake and clinical status.However, positron emission tomography (PET) is an extremely relevant examination for differentiating between true progression and pseudo-progression. Indeed, an increase in the transfer of amino acids in 18 F-dihydroxyphenylalanine (FDOPA)-PET strongly suggests a recurrence. A local treatment can then be proposed by favoring surgery or, as an option, radiotherapy under stereotactic conditions. However, this treatment, even if it is well tolerated, has an efficacy which could be improved.
Often proposed option to improve efficacy of this radiation technic consists in increasing the dose of irradiation. This dose increase is often limited by the tolerance of nearby healthy tissue. It could however be possible with coupled techniques of intensity modulation and stereotaxy within the framework of an integrated boost (Simultaneous Integrated Boost - SIB). At each radiation session, the dose delivered to the tumor volume would be increased in the metabolic volume (BTV) detected by FDOPA-PET.
The objective of this study is to evaluate, in patients with recurrent glioblastoma, the efficacy of a dose increase using an SIB in a volume delineated with FDOPA-PET.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Simultaneous-integrated boost with Intensity-modulated radiation therapy (IMRT)
* Planning Target Volume (PTV) 37,5 Gray (Gy): 37,5 Gy in 6 fractions of 6,25 Gy at the rate of one fraction each 2 days
* Prescription isodose line (PIL) at 80%, corresponding to 30 Gy as total dose, or 5 Gy per fraction
* PTV SIB 45 Gy: 45,0 Gy in 6 fractions of 7,50 Gy at the rate of one fraction each 2 days
* PIL at 80% corresponding to 36 Gy as total dose, or 6 Gy per fraction
Simultaneous-integrated boost with IMRT
Simultaneous-integrated boost guided by FDOPA-PET
Standard IMRT
* PTV 37,5 Gy: 37,5 Gy in 6 fractions of 6,25 Gy at the rate of one fraction each 2 days
* PIL at 80%, corresponding to 30 Gy as total dose, or 5 Gy per fraction
* No SIB
No interventions assigned to this group
Interventions
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Simultaneous-integrated boost with IMRT
Simultaneous-integrated boost guided by FDOPA-PET
Eligibility Criteria
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Inclusion Criteria
* Glioblastoma, World Health Organization (WHO) grade IV, histologically proven
* Performance status 0, 1 or 2
* Neurological status ≥ 2
* Past irradiation in previsional re-irradiated site or in the vicinity (5 to 7 cm)
* Radiological proven recurrence according to 1 and 2 criteria, Wen et al
* Remaining node after partial surgery post-recurrence
* 1 to 3 recurrence site(s) \< 35 mm in wide axis and separated by at least 5 mm
* Volume of each lesion \< 35 mL
* Distance between recurrence node(s) and optic nerves (left and right), chiasma and/or cerebral trunk \> 10 mm
Exclusion Criteria
* Glioblastomatose
* Pregnancy or breastfeeding
* Patient that do not understand French
* Patient without affiliation to the national or local social security
* Patients not able to comply to the protocol assessments for geographic, social or psychological reasons
* Minor or patients placed under guardianship or supervision
* Patients deprived of liberty
* Patients placed under judicial protection
* Patients that are not able to express their consent
18 Years
ALL
No
Sponsors
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Centre Georges François Leclerc
UNKNOWN
Institut de cancérologie Strasbourg Europe
OTHER
Responsible Party
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Locations
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Institut de cancérologie Strasbourg Europe
Strasbourg, , France
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2021-011
Identifier Type: -
Identifier Source: org_study_id
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