NCT05653635 Contribution From PET-DOPA in Glioblastoma Re-irradiation - A Randomized Phase II Study
| NCT ID | NCT05653635 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Centre Paul Strauss |
| Condition | Glioblastoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 54 participants |
| Start Date | 2026-03-01 |
| Primary Completion | 2028-09-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 54 participants in total. It began in 2026-03-01 with a primary completion date of 2028-09-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05653635 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Glioblastoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05653635 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT05653635 currently recruiting?
Yes, NCT05653635 is actively recruiting participants. Contact the research team at promotion-rc@institut-strauss.fr for enrollment information.
Where is the NCT05653635 trial being conducted?
This trial is being conducted at Nancy, France, Strasbourg, France.
Who is sponsoring the NCT05653635 clinical trial?
NCT05653635 is sponsored by Centre Paul Strauss. The trial plans to enroll 54 participants.
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