Clinical trial · Interventional
Contribution From PET-DOPA in Glioblastoma Re-irradiation - A Randomized Phase II Study
NCT05653635CI-TRIAL-00102375ReciDOPArecruitingPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Glioblastoma | Glioblastoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Simultaneous-integrated boost with IMRT | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Simultaneous-integrated boost with Intensity-modulated radiation therapy (IMRT)
- description
- * 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
- interventionNames
- Radiation: Simultaneous-integrated boost with IMRT
- type
- NO_INTERVENTION
- label
- Standard IMRT
- description
- * 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 outcomes (1)
- measure
- Efficacy of simultaneous-integrated boost with IMRT guided by FDOPA PET on Recurrence free survival in patient with recurrent glioblastoma
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.