Contribution From PET-DOPA in Glioblastoma Re-irradiation - A Randomized Phase II Study

Trial ID: NCT05653635

Interventional - Phase 2 - Recruiting

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.

Conditions

• Glioblastoma

Interventions

• Simultaneous-integrated boost with IMRT

Eligibility

Inclusion criteria

• Age \> 18 years
• 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

• Patient with contraindication to MRI or PET
• 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

Sponsor

Centre Paul Strauss, Centre Georges François Leclerc

Source: ClinicalTrials.gov

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