RecruitingPhase 2NCT05653622

Simultaneous Integrated Boost FDOPA Positron Emission Tomography (PET) Guided in Patients With Partially- or Non-operated Glioblastoma

Simultaneous Integrated Boost FDOPA PET Guided in Patients With Partially- or Non-operated Glioblastoma


Sponsor

Centre Paul Strauss

Enrollment

75 participants

Start Date

Jun 23, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

Glioblastoma (GBM) is the most common primary brain cancer in adults. Surgery, chemoradiotherapy (temozolomide TMZ) and then adjuvant TMZ is the standard treatment. But, most patients relapse in a median time of 8-9 months; the median overall survival (OS) ranged from 15 to 18 months. Some frail patients received hypofractionated radiation and concomitant and adjuvant TMZ. For some, the radiation dose is not optimal. Moreover, recurrences develop mainly in the initial tumor site. These two reasons justify increasing the dose. To limit the movements of these fragile patients, the method consists of increasing the dose without increasing the number of sessions by using the Simultaneous Integrated Boost (SIB) which increases the dose in targeted volumes while the rest of the volume receives a minimum dose. A phase I trial showed the possibility of increasing the dose in SIB up to 80 Gy in a part of the GBM enhanced on MRI. FDOPA PET detects certain more aggressive tumor areas, areas likely to recur. Integrating them into the SIB seems appropriate. A phase II trial showed the interest of SIB guided by FDOPA PET in terms of progression-free survival but without impact on OS. This study differed from the one the investigators propose, because a dose and conventional fractionation, identical to that of the European Organization for Research and Treatment of Cancer/National Cancer Information Center (NCIC/EORTC) protocol were delivered, the gliomas were unmethylated MGMT, less likely to respond. Studies with SIB and hypofractionation are often retrospective and for others, hypofractionation was debatable and the dose increase was not based on PET capture but on MRI. However, a prospective phase II study, with SIB and hypofractionation, not integrating FDopa PET has demonstrated the relevance of SIB. In this project, the investigators propose to use the integrated boost technique (SIB) guided by PET FDOPA to increase the radiation dose in GBM, in patients either fragile and partially operated, or only biopsied and for whom the prognosis is the most pejorative.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a type of personalized radiation treatment for patients with glioblastoma (an aggressive brain tumor) who are not suitable for the standard treatment plan. Researchers use a special brain imaging scan called PET-FDOPA to map the tumor more precisely and target radiation more accurately. **You may be eligible if...** - You are 18 or older with a confirmed glioblastoma diagnosis - You are not a candidate for the standard full chemoradiation treatment (STUPP protocol) - Your tumor shows up on PET-FDOPA imaging, allowing precise targeting - If over 70, you meet specific health and functional fitness criteria **You may NOT be eligible if...** - You are fit enough to receive the standard STUPP treatment - You have a contraindication to MRI or PET scans - Your radiation treatment area would overlap dangerously with critical brain structures Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREIntegrated boost technique (SIB) guided by PET FDOPA

intensity-modulated irradiation scheme with integrated boost technique (SIB) guided by PET FDOPA during the chemo-radiotherapy


Locations(3)

CHRU de Nancy

Nancy, De, France

Centre Paul Strauss

Strasbourg, France

ICL

Vandœuvre-lès-Nancy, France

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NCT05653622


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