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

Glioblastoma Multiforme Clinical Trial

— dualFETboost  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04790097
• Other study ID #: FET-PET SIB Boost
• Status: Completed
• Phase: N/A
• Start date: February 21, 2017
• Est. completion date: December 30, 2020

Study information

• Verified date: May 2021
• Source: Prof. Franciszek Lukaszczyk Memorial Oncology Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: December 30, 2020
• Est. primary completion date: December 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Glioblastoma
• Glioblastoma Multiforme

Intervention

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

Locations

Country	Name	City	State
Poland	The Franciszek Lukaszczyk Oncology Center	Bydgoszcz

Sponsors (1)

Lead Sponsor	Collaborator
Prof. Franciszek Lukaszczyk Memorial Oncology Center

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	FET predictive value	From date of surgery until the date of death from any cause, Correlation between FET uptake and survival	up to 24 months
Primary	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	assessed up to 24 months
Secondary	Progression Free Survival	from the date of surgery until progression of the disease or the date of death from any cause assessed	up to 24 months
Secondary	Objective response	according to Rano criteria; from the end of radiation therapy	up to 9 months
Secondary	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	up to 24 months
Secondary	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	assessed up to 24 months
Secondary	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	up to 6 months