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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
17
78Gy in 30 fractions on FET-PET based target volumes; 60Gy in 30 fractions on 2cm margin from MRI based target volumes; all patients will be treated with concomitant and adjuvant temozolomide
The Franciszek Lukaszczyk Oncology Center
Bydgoszcz, Poland
Overall survival
From date of surgery until the date of death from any cause, percent of patient that are alive 1 and 2 years after surgery
Time frame: assessed up to 24 months
Progression Free Survival
from the date of surgery until progression of the disease or the date of death from any cause assessed
Time frame: up to 24 months
Objective response
according to Rano criteria; from the end of radiation therapy
Time frame: up to 9 months
Location of treatment failure
from the end of radiation therapy up to progression until progression of the disease or the date of death from any cause; according to irradiation field
Time frame: up to 24 months
Radiation necrosis
from the end of radiation therapy up to progression until progression of the disease or the date of death from any cause; histopathological diagnosis of radiation necrosis
Time frame: assessed up to 24 months
Side effects
from the end of radiation therapy up to progression until progression of the disease or the date of death from any cause; CTCAE grade 3 or higher
Time frame: up to 6 months
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