PET-guided higher-dose targeted radiotherapy using a simultaneous integrated boost for partially- or non-operated glioblastoma
Simultaneous Integrated Boost FDOPA PET Guided in Patients With Partially- or Non-operated Glioblastoma
This tests whether giving a higher radiation dose to PET-identified aggressive tumor areas with a simultaneous integrated boost helps adults with partially- or non-operated glioblastoma who are not fit for standard Stupp treatment.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 75 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Centre Paul Strauss Academic / other |
| Drugs / interventions | radiation |
| Locations | 3 sites (Nancy, De and 2 other locations) |
| Trial ID | NCT05653622 on ClinicalTrials.gov |
What this trial studies
This Phase II approach uses 18F‑DOPA PET to map areas of increased amino-acid metabolism and defines a Biological Target Volume (BTV) for a simultaneous integrated boost (SIB) while the surrounding brain receives a lower dose. Frail or unfit patients who cannot undergo the standard Stupp protocol (surgery plus concurrent chemoradiation and adjuvant temozolomide) are enrolled in two cohorts based on operability, age, and functional status. Radiation planning aims to escalate dose to PET-positive regions using intensity-modulated techniques without increasing the number of treatment sessions, to limit movement and toxicity for fragile patients. The protocol builds on a Phase I experience that demonstrated feasibility of dose escalation to focused tumor regions on imaging.
Who should consider this trial
Good fit: Ideal candidates are adults with histologically proven glioblastoma who are unfit for the Stupp protocol (non-operable or partially resected), show FDOPA uptake allowing contouring of a BTV, and meet the trial Karnofsky/Balducci criteria.
Not a fit: Patients who are fit for standard Stupp therapy, those without FDOPA uptake, or whose targets are too close to critical structures like the optic chiasm and nerves are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, this approach could improve local tumor control and possibly extend survival by delivering higher dose to the most aggressive tumor areas while sparing normal tissue.
How similar studies have performed: A prior Phase I trial showed feasibility of SIB dose escalation up to 80 Gy in MRI-enhanced tumor areas, but FDOPA-guided SIB is relatively novel and has limited outcome data so far.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Unfit patient without indication to the STUPP protocol : Cohort 1 : Non-operable patients and ≥ 18 years old or ≤ 70 years old and Karnofsky Index (KI) ≥ 50% on inclusion AND Result of a biopsy available Cohort 2 : Patients \> 70 years old and Balducci score I or II and KI ≥ 60% on inclusion AND Partial resection (defined on the remnographic criteria of postoperative MRI) OR biopsy result available * Histologically proven glioblastoma * Increased metabolism of amino acids in PET FDOPA allowing contouring the Biological Target Volume (BTV) Exclusion Criteria: * Patients with an indication for irradiation according to the STUPP protocol (fit patient) * Patient with a contraindication to MRI or PET * Limit of the provisional target volume or Planning target volume (PTV), second PTV \< 2 cm from the chiasm and the optic nerves * Absence of uptake of FDopa
Where this trial is running
Nancy, De and 2 other locations
- CHRU de Nancy — Nancy, De, France (Recruiting)
- Centre Paul Strauss — Strasbourg, France (Recruiting)
- Icl — Vandœuvre-lès-Nancy, France (Recruiting)
Study contacts
- Principal investigator: Caroline BUND — Centre Paul Strauss
- Study coordinator: Anne ANTHONY
- Email: promotion-rc@institut-strauss.fr
- Phone: +33(0)388252413
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.