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NCT05653635
Contribution From PET-DOPA in Glioblastoma Re-irradiation
Conditions: Glioblastoma
Sex: All
Ages: 18 Years – N/A
Phase: PHASE2
Enrollment: 54
Sponsor: Institut de cancérologie Strasbourg Europe
Location: France
Summary
ReciDOPA is a phase II, single-stage randomized, multicenter, prospective trial assessing the efficacy of an irradiation protocol based on Intensity-modulated radiation therapy with simultaneous-integrated boost guided by FDOPA-PET in patient with recurrent glioblastoma.
Eligibility Criteria
Inclusion Criteria:Age > 18 yearsGlioblastoma, World Health Organization (WHO) grade IV, histologically provenPerformance status 0, 1 or 2Neurological status ≥ 2Past 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 alRemaining node after partial surgery post-recurrence1 to 3 recurrence site(s) < 35 mm in wide axis and separated by at least 5 mmVolume of each lesion < 35 mLDistance between recurrence node(s) and optic nerves (left and right), chiasma and/or cerebral trunk > 10 mmExclusion Criteria:Patient with contraindication to MRI or PETGlioblastomosisPregnancy or breastfeedingPatient that do not understand FrenchPatient without affiliation to the national or local social securityPatients not able to comply to the protocol assessments for geographic, social or psychological reasonsMinor or patients placed under guardianship or supervisionPatients deprived of libertyPatients placed under judicial protectionPatients that are not able to express their consent
Source: ClinicalTrials.gov (NCT05653635). StuddyBuddy aggregates publicly available trial information.