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

RecruitingPhase 2Ages 18 Years - anyAllCentre Paul Strauss
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
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
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What it tests

  • Integrated boost technique (SIB) guided by PET FDOPA
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Where

3 sites
CHRU de Nancy
Nancy, France
Centre Paul Strauss
Strasbourg, France
ICL
Vandœuvre-lès-Nancy, France
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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