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Completed

NCT Number: NCT04790097

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

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.

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Key information

Conditions

Glioblastoma Multiforme Astrocytoma Glioblastoma Glioma Neoplasms Neoplasms by Histologic Type Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neoplasms, Neuroepithelial Neuroectodermal Tumors

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Franciszek Lukaszczyk Oncology Center

Bydgoszcz, Poland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Moderately Hypofractionated Radiotherapy using Simultaneous In-Field Boost

Radiation

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

Primary outcomes

  1. Overall survival

    Time frame: assessed up to 24 months

    From date of surgery until the date of death from any cause, percent of patient that are alive 1 and 2 years after surgery

Secondary outcomes

  1. Progression Free Survival

    Time frame: up to 24 months

    from the date of surgery until progression of the disease or the date of death from any cause assessed

  2. Objective response

    Time frame: up to 9 months

    according to Rano criteria; from the end of radiation therapy

  3. Location of treatment failure

    Time frame: up to 24 months

    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

  4. Radiation necrosis

    Time frame: assessed up to 24 months

    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

  5. Side effects

    Time frame: up to 6 months

    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

Other outcomes

  1. FET predictive value

    Time frame: up to 24 months

    From date of surgery until the date of death from any cause, Correlation between FET uptake and survival

Sponsors and collaborators

Lead sponsor

Prof. Franciszek Lukaszczyk Memorial Oncology Center

Other

Registry information

Official study title

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

Acronym: dualFETboost

Important dates

Study start
2017
Primary completion
2019
Study completion
2020
First posted
Mar 10, 2021
Registry last updated
May 6, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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