FET-PET Directed Simultaneous In-field Boost for Primary GBM (dualFETboost)

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

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.

Study Overview

• Status: Completed
• Conditions: Glioblastoma Multiforme
• Intervention / Treatment: Radiation: Moderately Hypofractionated Radiotherapy using Simultaneous In-Field Boost

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.

• Study Type: Interventional
• Enrollment (Actual): 17
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Poland
  • Bydgoszcz, Poland
    • The Franciszek Lukaszczyk Oncology Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Simultaneous In-Field Boost on FET-PET positive target volumes	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Objective response	according to Rano criteria; from the end of radiation therapy	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	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	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	up to 6 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Prof. Franciszek Lukaszczyk Memorial Oncology Center

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): February 21, 2017
• Primary Completion (Actual): December 30, 2019
• Study Completion (Actual): December 30, 2020

Study Registration Dates

• First Submitted: January 23, 2021
• First Submitted That Met QC Criteria: March 8, 2021
• First Posted (Actual): March 10, 2021

Study Record Updates

• Last Update Posted (Actual): May 6, 2021
• Last Update Submitted That Met QC Criteria: May 4, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Keywords: Glioblastoma; Dose-escalation; Boost; FET-PET; Dose-intesification
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Glioblastoma
• Other Study ID Numbers: FET-PET SIB Boost

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No