Glioblastoma MultiformedualFETboostNCT04790097
FET-PET Directed Simultaneous In-field Boost for Primary GBM
A study testing Moderately Hypofractionated Radiotherapy using Simultaneous In-Field Boost in people with Glioblastoma Multiforme, run by Prof. Franciszek Lukaszczyk Memorial Oncology Center at 1 site in Poland.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glioblastoma Multiforme
- What is being tested?
- Moderately Hypofractionated Radiotherapy using Simultaneous In-Field Boost
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 sitePoland
- Study dates
- 21 Feb 2017to 30 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- Pregnancy, lack of consent to the use of protection against pregnancy, puerperium
- Alcohol addiction
- Mental illness
- Claustrophobia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Being tested
- Moderately Hypofractionated Radiotherapy using Simultaneous In-Field Boost
- Keywords
- FET-PET, Boost, Glioblastoma, Dose-intesification, Dose-escalation
- Medical subject headings
- Glioblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| Simultaneous In-Field Boost on FET-PET positive target volumes | Experimental | Not described Receives: Radiation: Moderately Hypofractionated Radiotherapy using Simultaneous In-Field Boost |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: assessed up to 24 months
Secondary outcomes (5)
Progression Free Survival
from the date of surgery until progression of the disease or the date of death from any cause assessed
Measured: up to 24 months
Objective response
according to Rano criteria; from the end of radiation therapy
Measured: 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
Measured: 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
Measured: 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
Measured: up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2021
- Study start21 Feb 2017
- Primary completion30 Dec 2019
- Study completion30 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Glioblastoma MultiformeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prof. Franciszek Lukaszczyk Memorial Oncology Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maciej Harat, Prof. Franciszek Lukaszczyk Memorial Oncology Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04790097
- Sponsor's protocol ID
- FET-PET SIB Boost
- Acronym
- dualFETboost
- Status last verified
- May 2021
- First submitted
- 23 Jan 2021
- Last updated
- 6 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 35552391
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Preliminary Efficacy of Hipofractionated Irradiation Based on Dual FET-PET in Patients With Primary Glioblastoma Multiforme With Concomitant Temozolomide
- ClinicalTrials.gov ID
- NCT04790097
- Acronym / sponsor ID
- dualFETboost / FET-PET SIB Boost
- Conditions
- Glioblastoma Multiforme
- Keywords
- FET-PET, Boost, Glioblastoma, Dose-intesification, Dose-escalation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Prof. Franciszek Lukaszczyk Memorial Oncology CenterUniversity, hospital or other
- Study start
- 21 Feb 2017 (actual)
- Primary completion
- 30 Dec 2019 (actual)
- Study completion
- 30 Dec 2020 (actual)
- First posted
- 10 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Simultaneous In-Field Boost on FET-PET positive target volumes | Experimental | Radiation: Moderately Hypofractionated Radiotherapy using Simultaneous In-Field Boost |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Moderately Hypofractionated Radiotherapy using Simultaneous In-Field Boost78Gy 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 | Radiation | Simultaneous In-Field Boost on FET-PET positive target volumes |
Primary outcome
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
5 secondary outcomes
Progression Free Survival
Time frame: up to 24 months
Objective response
Time frame: up to 9 months
Location of treatment failure
Time frame: up to 24 months
Radiation necrosis
Time frame: assessed up to 24 months
Side effects
Time frame: up to 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2021.
- Derived from this study: PubMed 35552391Harat 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Moderately Hypofractionated Radiotherapy using Simultaneous In-Field Boost in people with Glioblastoma Multiforme, run by Prof. Franciszek Lukaszczyk Memorial Oncology Center at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (time frame: assessed up to 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04790097, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2021.