Clinical trial NCT04790097: FET-PET Directed Simultaneous In-field Boost for Primary GBM
Official title: Safety and Preliminary Efficacy of Hipofractionated Irradiation Based on Dual FET-PET in Patients With Primary Glioblastoma Multiforme With Concomitant Temozolomide
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Glioblastoma Multiforme
Keywords: FET-PET
Boost
Glioblastoma
Dose-intesification
Dose-escalation
Lead sponsor: Prof. Franciszek Lukaszczyk Memorial Oncology Center
Sponsor class: OTHER
First posted: 2021-03-10
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The combination of anatomical MRI examination with functional examination of tissue metabolic activity such as FET-PET (PET using the radiotracer - 18F-fluoro-ethyl-tyrosine) is a valuable tool to determine the actual tumor infiltration. The FET-PET examination can be performed using the dual-time point aqusition of FET for exact treatment planning. It has also been proven that using the dual FET-PET method, it is possible to obtain a precise image of the glioblastoma infiltration corresponding to the location and shape of the recurrence, and the tumor volumes in dual FET-PET are significantly larger than in MRI. Moreover, tumor defined in dual FET-PET is different than that of the tumor defined in single FET-PET acquisition.

In the DualFETboosT trial we plan to assess the safety and preliminary efficacy of hypofractionated irraditon using simultaneous in-field boost directed on dual FET-PET based tumor volumes for treatment of primary glioblastoma multiforme with concomitant temozolomide.

Detailed description: In the case of the treatment of glioblastoma multiforme, as a standard, radiotherapy lasts 6 weeks, and the extension of treatment may adversely affect the tumor cells death, the patient's well-being and treatment costs (prolonged hospitalization). In turn, escalating the dose may increase the toxicity of radiation therapy by increasing DNA damage in healthy brain tissue. Using of dual FET-PET images for treatment planning allow to reduce volumes of healthy tissue irradiated. Dose-intensification proposed in the study using simultaneous in-field boost allows the dose escalation without increasing the overall treatment time. All patient will be treated with moderately hypofractionated radiotherapy (2.6 Gy per fraction) directed on PET positive volumes and conventional fractionation (60Gy in 30 fractions) on tumor margin.

Eligibility criteria: Inclusion Criteria:

* Histopathological confirmation of glioblastoma (WHO grade IV)
* Age between 18-75 years of age
* General condition according to the Zubrod scale 0 or 2
* The results of the blood counts are normal
* Liver enzyme parameters normal
* The results of the parameters of the patient's functions are normal
* Informed consent to participate in the category

Exclusion Criteria:

* Coexistence of another cancer
* The location of the tumor in the area of the brain stem or cerebellum
* Prior brain radiation therapy
* No uptake visible in the FET-PET imaging
* Contraindications for MRI
* Contraindications to radiotherapy or chemotherapy
* Pregnancy, lack of consent to the use of protection against pregnancy, puerperium
* Alcohol addiction
* Mental illness
* Claustrophobia

Primary outcomes:
measure: Overall survival
timeFrame: assessed up to 24 months
Secondary outcomes:
measure: Progression Free Survival
timeFrame: up to 24 months
measure: Objective response
timeFrame: up to 9 months
measure: Location of treatment failure
timeFrame: up to 24 months
measure: Radiation necrosis
timeFrame: assessed up to 24 months
measure: Side effects
timeFrame: up to 6 months
Other outcomes:
measure: FET predictive value
timeFrame: up to 24 months
Locations:
city: Bydgoszcz
country: Poland
facility: The Franciszek Lukaszczyk Oncology Center
Study officials:
References:
citation: Harat M, Blok M, Miechowicz I, Wiatrowska I, Makarewicz K, Malkowski B. Safety and Efficacy of Irradiation Boost Based on 18F-FET-PET in Patients with Newly Diagnosed Glioblastoma. Clin Cancer Res. 2022 Jul 15;28(14):3011-3020. doi: 10.1158/1078-0432.CCR-22-0171.