NCT04790097

FET-PET Directed Simultaneous In-field Boost for Primary GBM

Safety and Preliminary Efficacy of Hipofractionated Irradiation Based on Dual FET-PET in Patients With Primary Glioblastoma Multiforme With Concomitant Temozolomide

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 17 (actual)
• Sponsor: Prof. Franciszek Lukaszczyk Memorial Oncology Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Glioblastoma Multiforme

Interventions

Type	Name	Description
RADIATION	Moderately Hypofractionated Radiotherapy using Simultaneous In-Field Boost	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

Timeline

• Start date: 2017-02-21
• Primary completion: 2019-12-30
• Completion: 2020-12-30
• First posted: 2021-03-10
• Last updated: 2021-05-06

Locations

1 site across 1 country: Poland