FDOPA PET-guided IMRT simultaneous-integrated boost for recurrent glioblastoma
Official title: Contribution From PET-DOPA in Glioblastoma Re-irradiation - A Randomized Phase II Study
Run by Centre Paul Strauss · NCT05653635 · Data updated 2026-11-12
This trial will try using FDOPA PET scans to guide a higher‑dose simultaneous‑integrated boost IMRT re-irradiation for adults with recurrent glioblastoma to better target tumor while protecting healthy brain.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 54 (estimated) |
| Sponsor | Centre Paul Strauss Academic / other |
| Drugs / interventions | radiation, bevacizumab, chemotherapy |
| Locations | 2 sites (Nancy, De and 1 other locations) |
| Status | Recruiting |
| Started | March 1, 2026 |
| Main results expected | September 1, 2028 |
| Study ends | September 1, 2028 |
| Registry record updated | February 4, 2026 |
| Trial ID | NCT05653635 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (age >18) with histologically proven WHO grade IV glioblastoma, performance status 0–2, 1–3 focal recurrences each <35 mm and <35 mL, prior radiotherapy, and safe distances from optic apparatus and brainstem are ideal candidates.
✕Probably not a fit
Patients with diffuse gliomatosis, more than three or larger recurrent lesions, lesions too close to optic nerves/chiasm or brainstem, pregnancy, inability to undergo MRI/PET, or who cannot comply with study procedures are unlikely to benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
ReciDOPA is a randomized, multicenter Phase II trial that tests an IMRT re-irradiation protocol using a simultaneous‑integrated boost whose boost volume is defined by FDOPA PET imaging. Eligible adults with histologically proven recurrent glioblastoma and limited focal recurrence are randomized to FDOPA PET‑guided boost planning versus standard imaging‑based planning. Patients receive focused re-irradiation with close imaging and clinical follow‑up to measure local control, survival, steroid use, and toxicity. The trial aims to determine whether PET guidance can improve outcomes without increasing unacceptable brain toxicity.
Why it matters
Potential benefit: If successful, this approach could improve local tumor control and survival while reducing radiation exposure to healthy brain tissue.
How similar studies have gone: Smaller observational and imaging studies suggest amino‑acid PET (including FDOPA) better delineates recurrent tumor and can guide targeted radiotherapy, but randomized Phase II evidence has been limited until now.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
-
Centre Paul Strauss
Strasbourg, France Recruiting -
CHRU de Nancy
Nancy, De, France Not yet recruiting
Study contacts
- Study coordinator: Anne ANTHONY
- Email: promotion-rc@institut-strauss.fr
- Phone: (0)388252413
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.