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

RECRUITINGPhase 2Sponsored by Centre Paul Strauss
Actively Recruiting
PhasePhase 2
SponsorCentre Paul Strauss
Started2026-03-01
Est. completion2028-09-01
Eligibility
Age18 Years+
Healthy vol.Accepted
View on ClinicalTrials.gov →

NCT05653635

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

Age: 18 Years+Healthy volunteers accepted
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

Conditions2

CancerGlioblastoma

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