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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Simultaneous In-Field Boost on FET-PET positive target volumes | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| 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 |
| 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 |
| 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Franciszek Lukaszczyk Oncology Center | Bydgoszcz | Poland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35552391 | Derived | 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. |
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| ID | Term |
|---|---|
| D005909 | Glioblastoma |
| ID | Term |
|---|---|
| D001254 | Astrocytoma |
| D005910 | Glioma |
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
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|
| 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 |
| D009373 |
| Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |