- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne NCT07710040
Preoperative Proton Irradiation for High-grade Brain Gliomas. (PPrestige)
Proton PREoperative STereotactic Irradiaiton for High-grade Gliomas (PPrestige): a Single-center Prospective Interventional Pahse 1 Trial
The goal of this clinical trial is to learn if preopearative proton therapy (PPT) is tolerable in patients with High-grade brain gliomas. It will also learn about the influence on surgical procedure, clinical effects and safety of regular treatment.
The main questions it aims to answer are:
Does preoprative proton therapy well-tolerated? What maximal dose of PPT is safe?
Proposed Treatment Stages
- Multidisciplinary board (neurosurgeon, radiation therapist, and medical oncologist) decision of patient enrollment.
- Course of preoperative proton stereotactic radiotherapy (PSRT) directed at the tumor only: GTV=contrast-part of brain giloma, CTV=GTV. Dose regimens: first 3 patients - 4 Gy(RBE) × 5 fractions; subsequent 3 patients - 5 Gy(RBE) × 5 fractions; subsequent 3 patients - 6 Gy(RBE) × 5 fractions. RBE = Relative biological efficacy, equal 1.1 for protons. Should any information regarding unacceptable treatment toxicity emerge, the study will be terminated.
- Microsurgical resection of the contrast-enhancing portion of the tumor using fluorescence microscopy and, when indicated, neurophysiological monitoring.
- Contrast-enhanced MRI to assess the resection volume within the first 24-48 hours after surgery.
- Follow-up evaluation - clinical, morphological, and radiological assessment of the effects of the preoperative and surgical treatment stages, performed 3-4 weeks after the surgical phase.
- Standard treatment and follow-up: Chemoradiotherapy with a scanned proton beam combined with temozolomide 75 mg/m², given at 2 Gy × 30 fractions, to commence 4-6 weeks after surgery. Adjuvant chemotherapy with temozolomide 150-200 mg/m² on a 5/23 schedule (maintenance chemotherapy), for 12 cycles or until disease progression/unacceptable toxicity.
- Follow-up - control examinations every 1 month after completion of chemoradiotherapy, then every 3 months for the first year.
Przegląd badań
Status
Warunki
Interwencja / Leczenie
Szczegółowy opis
High grade gliomas (HGG), especially glioblastomas, are among those disease, for which oncological science doesn't propose any improvements for several decades, since temozolomide became a part of therapy. Preoperative irradiation is a standard of care for various malignant diseases. Historically, for intracranial targets preoperative RT is a taboo. Besides, recent data from preoperative RT of brain metastasis showed promising results and good toxicity profile. We would like to investigate the hypotheses of preoprative proton short-course irradiation can be tolerable and potentially improve outcomes in HGG patients.
High-grade gliomas (astrocytomas CNS WHO grade 3-4, glioblastomas, etc) are the most common primary brain tumors, with an extremely poor survival prognosis and a median overall survival of approximately 15-18 months [1, 2]. Recent advances in drug therapy have, unfortunately, not made a substantial contribution to improving treatment outcomes. Therefore, novel approaches to enhance treatment efficacy are more relevant than ever, and over the past decades, the use of radiotherapy has indeed improved survival in these patients. The standard treatment protocol currently includes maximal safe surgical resection followed by chemoradiotherapy, which is initiated 4-6 weeks after surgery [3]. However, microscopic foci of tumor cells in the postoperative period may proliferate and become manifest even before the start of radiotherapy. A recent meta-analysis showed that 40-50 % of patients with high-grade gliomas experience disease progression already during the interval between surgery and adjuvant treatment [4]. Since complete tumor resection is virtually unattainable, intensification of preoperative treatment may represent an effective option, as it targets the disease at an earlier and potentially more vulnerable stage [5].
There is considerable interest in early treatment strategies for high-grade gliomas that target the pre-, intra-, or early postoperative tumor microenvironment [5]. Preoperative radiotherapy is of particular interest, given the encouraging results observed in many other tumor types; however, it has never been applied to high-grade gliomas before [6, 7, 8, 9]. The preoperative period offers more favorable therapeutic characteristics compared with the postoperative tumor microenvironment, including less tumor hypoxia and molecular heterogeneity, which may consequently enhance the effectiveness of irradiation at this stage [5]. Data from dose-escalation safety studies suggest that a radiation dose additional to the standard postoperative regimen (60 Gy/30 fractions) can be delivered safely, but it remains unclear whether dose escalation can improve patient outcomes [10]. Currently, there are only a limited number of studies on preoperative radiotherapy for high-grade gliomas at various stages of preclinical and clinical investigation [6, 11, 12].
Proton therapy is currently the most sparing modality of radiotherapy, allowing, through its unique dose-distribution characteristics, a significant reduction in exposure to normal tissues-a particularly important consideration when irradiating the brain [13]. The use of proton therapy has been widely established both in primary tumors of the nervous system, including extreme dose escalation in glioblastomas, and in re-irradiation settings [14, 15]. Accumulated clinical experience suggests that the application of protons in the pre- and postoperative setting in patients with high-grade gliomas of the brain may minimize the risks of radiation complications and open up new therapeutic opportunities for this disease.
Typ studiów
Zapisy (Szacowany)
Faza
- Faza 1
Kontakty i lokalizacje
Kontakt w sprawie studiów
- Nazwa: Konstantin Gordon, PhD
- Numer telefonu: 0079105184148
- E-mail: gordonkb@nmicr.ru
Lokalizacje studiów
-
-
Kaluga Oblast
-
Obninsk, Kaluga Oblast, Rosja, 249036
- Rekrutacyjny
- Proton Therapy Department, A. Tsyb Medical Radiological Research Center - branch of the National Medical Radiological Research Center
-
Kontakt:
- Konstantin Gordon, PhD
- Numer telefonu: 0079105184148
- E-mail: gordonkb@nmicr.ru
-
-
Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dorosły
- Starszy dorosły
Akceptuje zdrowych ochotników
Opis
Inclusion Criteria:
- radiologically confirmed (MRI and/or PET with amino-acids) diagnosis of high-grade glioma
- single foci
- ECOG 0-2 status
- tumor location and volume, eligible for gross total resection (GTR)
- signed informed consent
Exclusion Criteria:
- multifocal disease
- ECOG 3-4
- inability to achieve GTR
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Nie dotyczy
- Model interwencyjny: Zadanie dla jednej grupy
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
|
Eksperymentalny: Patients with radiological signs of single-focal high-grade glioma
|
After enrollment patientswith radiological signs of HGG will be irradiated by pencil beam protons in the following regimens: 3 pts - 4 GyRBE (RBE = 1.1) x 5 Fx; 3 pts - 5 GyRBE x 5 Fx; 3pts - 6 GyRBE x 5 Fx.
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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Acute and late radiation-induced toxicity
Ramy czasowe: 12 months
|
Primary endpoint is to evaluate the safety of preoperative proton stereotactic radiotherapy regimens for HGG based on the incidence and severity of early (up to 3 months) and late (>6 months) radiation-caused complications.
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12 months
|
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Clinical effects
Ramy czasowe: 12 months
|
To evaluate the clinical effects of postoperative proton beam therapy for HGG based on progression-free survival and overall survival rates during the following intervals: 1) between surgery and chemoradiotherapy and 2) after the chemoradiotherapy phase.
|
12 months
|
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Maximal dose of preoperative irradiation
Ramy czasowe: 12 months
|
To assess the tolerable dose of preoperative radiotherapy based on the irradiation regimen and tumor volume.
|
12 months
|
|
Postoperative safety
Ramy czasowe: 12 months
|
To evaluate the safety of postoperative chemoradiotherapy, based on the incidence and severity of early (up to 3 months) and late (>6 months) complications.
|
12 months
|
Inne miary wyników
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Neurosurgical features
Ramy czasowe: during surgery
|
To evaluate the specific features of the neurosurgical intervention following preoperative irradiation.
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during surgery
|
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Morphological and genetic features
Ramy czasowe: 12 months
|
To evaluate the morphological characteristics and molecular-biological profile of the tumor tissue following the surgical treatment phase.
Assess circulating tumor DNA at various stages of treatment.
|
12 months
|
Współpracownicy i badacze
Śledczy
- Główny śledczy: Igor Gulidov, A. Tsyb MRRC
- Główny śledczy: Alexey Goryanov, A. Tsyb MRRC
Publikacje i pomocne linki
Publikacje ogólne
- Stupp R, Mason WP, van den Bent MJ, Weller M, Fisher B, Taphoorn MJ, Belanger K, Brandes AA, Marosi C, Bogdahn U, Curschmann J, Janzer RC, Ludwin SK, Gorlia T, Allgeier A, Lacombe D, Cairncross JG, Eisenhauer E, Mirimanoff RO; European Organisation for Research and Treatment of Cancer Brain Tumor and Radiotherapy Groups; National Cancer Institute of Canada Clinical Trials Group. Radiotherapy plus concomitant and adjuvant temozolomide for glioblastoma. N Engl J Med. 2005 Mar 10;352(10):987-96. doi: 10.1056/NEJMoa043330.
- Ivy SP, Siu LL, Garrett-Mayer E, Rubinstein L. Approaches to phase 1 clinical trial design focused on safety, efficiency, and selected patient populations: a report from the clinical trial design task force of the national cancer institute investigational drug steering committee. Clin Cancer Res. 2010 Mar 15;16(6):1726-36. doi: 10.1158/1078-0432.CCR-09-1961. Epub 2010 Mar 9.
- Waqar M, Roncaroli F, Lehrer EJ, Palmer JD, Villanueva-Meyer J, Braunstein S, Hall E, Aznar M, De Witt Hamer PC, D'Urso PI, Trifiletti D, Quinones-Hinojosa A, Wesseling P, Borst GR. Rapid early progression (REP) of glioblastoma is an independent negative prognostic factor: Results from a systematic review and meta-analysis. Neurooncol Adv. 2022 Jun 4;4(1):vdac075. doi: 10.1093/noajnl/vdac075. eCollection 2022 Jan-Dec.
- McClelland S 3rd, Yeboa DN. The Emerging Paradigm of Preoperative Stereotactic Radiosurgery for Resectable Brain Metastases. JAMA Oncol. 2023 Aug 1;9(8):1073-1074. doi: 10.1001/jamaoncol.2023.1342. No abstract available.
- Bisello S, Cilla S, Benini A, Cardano R, Nguyen NP, Deodato F, Macchia G, Buwenge M, Cammelli S, Wondemagegnehu T, Uddin AFMK, Rizzo S, Bazzocchi A, Strigari L, Morganti AG. Dose-Volume Constraints fOr oRganS At risk In Radiotherapy (CORSAIR): An "All-in-One" Multicenter-Multidisciplinary Practical Summary. Curr Oncol. 2022 Sep 27;29(10):7021-7050. doi: 10.3390/curroncol29100552.
- Dohopolski M, Schmitt LG, de Vis J, Mostardeiro TR, Anand S, Youssef M, Noch E, Maher E, Sun M, Patel T, Patel A, Barnett S, Lee M, Iakovenko V, Chiu T, Su FC, Pompos A, Lin MH, Cai X, Timmerman R, Dan T, Wardak Z. Comparative Outcomes of Standard Radiation Therapy and 5-Fraction Adaptive Stereotactic Radiation Therapy in Newly Diagnosed Glioblastoma: A Propensity Score-Matched Analysis. Adv Radiat Oncol. 2025 May 18;10(8):101813. doi: 10.1016/j.adro.2025.101813. eCollection 2025 Aug.
- Gulidov I, Gordon K, Semenov A, Gogolin D, Lepilina O, Golovanova O, Dujenko S, Medvedeva K, Koryakin S, Ivanov S, Kaprin A. Proton re-irradiation of unresectable recurrent brain gliomas: clinical outcomes and toxicity. J BUON. 2021 May-Jun;26(3):970-976.
- Matsuda M, Mizumoto M, Kohzuki H, Sugii N, Sakurai H, Ishikawa E. High-dose proton beam therapy versus conventional fractionated radiation therapy for newly diagnosed glioblastoma: a propensity score matching analysis. Radiat Oncol. 2023 Feb 23;18(1):38. doi: 10.1186/s13014-023-02236-1.
- Kiseleva V, Gordon K, Vishnyakova P, Gantsova E, Elchaninov A, Fatkhudinov T. Particle Therapy: Clinical Applications and Biological Effects. Life (Basel). 2022 Dec 9;12(12):2071. doi: 10.3390/life12122071.
- Fernandez-Gil BI, Schiapparelli P, Navarro-Garcia de Llano JP, Otamendi-Lopez A, Ulloa-Navas MJ, Michaelides L, Vazquez-Ramos CA, Herchko SM, Murray ME, Cherukuri Y, Asmann YW, Trifiletti DM, Quinones-Hinojosa A. Effects of PreOperative radiotherapy in a preclinical glioblastoma model: a paradigm-shift approach. J Neurooncol. 2024 Sep;169(3):633-646. doi: 10.1007/s11060-024-04765-5. Epub 2024 Jul 22.
- Waqar M, Roncaroli F, Djoukhadar I, Akkari L, O'Leary C, Hewitt L, Forte G, Jackson R, Hessen E, Withington L, Beasley W, Richardson J, Golby C, Whitehurst P, Colaco R, Bailey M, Karabatsou K, D'Urso PI, McBain C, Coope DJ, Borst GR. Study protocol: PreOperative Brain Irradiation in Glioblastoma (POBIG) - A phase I trial. Clin Transl Radiat Oncol. 2023 Jan 18;39:100585. doi: 10.1016/j.ctro.2023.100585. eCollection 2023 Mar.
- Novikov SN, Gafton GI, Ebert MA, Fedosova EA, Melnik JS, Zinovev GV, Gafton IG, Sinyachkin MS, Kanaev SV. Preoperative stereotactic ablative body radiotherapy with postoperative conventional irradiation of soft tissue sarcomas: Protocol overview with a preliminary safety report. Radiother Oncol. 2021 Aug;161:126-131. doi: 10.1016/j.radonc.2021.05.025. Epub 2021 Jun 2.
- 9. V. Gondi, S. Pugh, C. Tsien, T. Chenevert, M. Gilbert, A. Omuro, et al. Radiotherapy (RT) dose-intensification (DI) using intensity-modulated RT (IMRT) versus standard-dose (SD) RT with temozolomide (TMZ) in Newly Diagnosed Glioblastoma (GBM): preliminary results of NRG oncology BN001. Int J Radiat Oncol Biol Phys, 108 (2020), pp. S22-S23, 10.1016/j.ijrobp.2020.07.2109
- Bonvalot S, Gronchi A, Le Pechoux C, Swallow CJ, Strauss D, Meeus P, van Coevorden F, Stoldt S, Stoeckle E, Rutkowski P, Rastrelli M, Raut CP, Hompes D, De Paoli A, Sangalli C, Honore C, Chung P, Miah A, Blay JY, Fiore M, Stelmes JJ, Dei Tos AP, Baldini EH, Litiere S, Marreaud S, Gelderblom H, Haas RL. Preoperative radiotherapy plus surgery versus surgery alone for patients with primary retroperitoneal sarcoma (EORTC-62092: STRASS): a multicentre, open-label, randomised, phase 3 trial. Lancet Oncol. 2020 Oct;21(10):1366-1377. doi: 10.1016/S1470-2045(20)30446-0. Epub 2020 Sep 14.
- Lee G, Strickland MR, Wo JY. Role of Preoperative Radiation Therapy for Resectable Gastric Cancer. J Gastrointest Cancer. 2024 Jun;55(2):584-598. doi: 10.1007/s12029-023-00985-6. Epub 2024 Feb 14.
- Lehrer EJ, Ruiz-Garcia H, Nehlsen AD, Sindhu KK, Estrada RS, Borst GR, Sheehan JP, Quinones-Hinojosa A, Trifiletti DM. Preoperative Stereotactic Radiosurgery for Glioblastoma. Biology (Basel). 2022 Jan 26;11(2):194. doi: 10.3390/biology11020194.
- Waqar M, Trifiletti DM, McBain C, O'Connor J, Coope DJ, Akkari L, Quinones-Hinojosa A, Borst GR. Early Therapeutic Interventions for Newly Diagnosed Glioblastoma: Rationale and Review of the Literature. Curr Oncol Rep. 2022 Mar;24(3):311-324. doi: 10.1007/s11912-021-01157-0. Epub 2022 Feb 4.
- Buszek SM, Al Feghali KA, Elhalawani H, Chevli N, Allen PK, Chung C. Optimal Timing of Radiotherapy Following Gross Total or Subtotal Resection of Glioblastoma: A Real-World Assessment using the National Cancer Database. Sci Rep. 2020 Mar 18;10(1):4926. doi: 10.1038/s41598-020-61701-z.
- Cantrell JN, Waddle MR, Rotman M, Peterson JL, Ruiz-Garcia H, Heckman MG, Quinones-Hinojosa A, Rosenfeld SS, Brown PD, Trifiletti DM. Progress Toward Long-Term Survivors of Glioblastoma. Mayo Clin Proc. 2019 Jul;94(7):1278-1286. doi: 10.1016/j.mayocp.2018.11.031. Epub 2019 Jun 20.
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Szacowany)
Zakończenie podstawowe (Szacowany)
Ukończenie studiów (Szacowany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Inne numery identyfikacyjne badania
- 29_06_2026_PPrestige
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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