RecruitingPhase 2NCT05653635

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

Sponsor

Centre Paul Strauss

Enrollment

54 participants

Start Date

Mar 1, 2026

Study Type

INTERVENTIONAL

Conditions

Glioblastoma

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

Min Age: 18 Years

Inclusion Criteria10

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
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 Criteria10

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