NCT04790097

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
17

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 21, 2017

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2019

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2020

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

January 23, 2021

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 10, 2021

Completed
Last Updated

May 6, 2021

Status Verified

May 1, 2021

Enrollment Period

2.9 years

First QC Date

January 23, 2021

Last Update Submit

May 4, 2021

Conditions

Glioblastoma Multiforme

Keywords

FET-PETBoostGlioblastomaDose-intesificationDose-escalation

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • Progression Free Survival

    up to 24 months

  • Objective response

    up to 9 months

  • Location of treatment failure

    up to 24 months

  • Radiation necrosis

    assessed up to 24 months

  • Side effects

    up to 6 months

Other Outcomes (1)

  • FET predictive value

    up to 24 months

Study Arms (1)

Simultaneous In-Field Boost on FET-PET positive target volumes

EXPERIMENTAL
Radiation: Moderately Hypofractionated Radiotherapy using Simultaneous In-Field Boost

Interventions

Moderately Hypofractionated Radiotherapy using Simultaneous In-Field BoostRADIATION

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

Simultaneous In-Field Boost on FET-PET positive target volumes

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Franciszek Lukaszczyk Oncology Center

Bydgoszcz, Poland

Location

Related Publications (1)

  • 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.

    PMID: 35552391DERIVED

MeSH Terms

Conditions

Glioblastoma

Condition Hierarchy (Ancestors)

AstrocytomaGliomaNeoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Glandular and EpithelialNeoplasms, Nerve Tissue

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D Ph.D.

Study Record Dates

First Submitted

January 23, 2021

First Posted

March 10, 2021

Study Start

February 21, 2017

Primary Completion

December 30, 2019

Study Completion

December 30, 2020

Last Updated

May 6, 2021

Record last verified: 2021-05

Locations

PL(1)