PET-guided higher-dose targeted radiotherapy using a simultaneous integrated boost for partially- or non-operated glioblastoma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.