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

Sponsor
Centre Paul Strauss
Study ID
NCT05653635
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Simultaneous-integrated boost with IMRT — RADIATION
    Simultaneous-integrated boost guided by FDOPA-PET

Study Details

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.

Key Dates

First listed
Dec 16, 2022
Start date
Mar 1, 2026
Status verified
Feb 2026
Primary completion
Sep 1, 2028
Completion
Sep 1, 2028

Study Design

Enrollment
54 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: 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
  • No Intervention: 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

Primary Outcome Measure

Efficacy of simultaneous-integrated boost with IMRT guided by FDOPA PET on Recurrence free survival in patient with recurrent glioblastoma [ Time Frame: up to 24 months ]

Central Contacts

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