NCT06831773|Recruiting
Clinical Study of Carbon Ion Radiotherapy for High-grade Glioma
Phase II Clinical Study of Carbon Ion Combined with Photon Radiotherapy for High-grade Glioma
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Phase II Clinical Study of Carbon Ion Combined with Photon Radiotherapy for High-grade Glioma
Sponsor study identifier
interventional
23
1 country
1
Study Start
February 1, 2025
Actual (reported)Primary Completion
December 31, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
December 31, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
The objective is to use the advantages of heavy ion physical dosimetry and biology to improve the tumor control rate and long-term survival rate of high-grade glioma, reduce the occurrence of brain tissue radiation damage caused by increasing prescription dose, and provide new treatment suggestions for glioma radiotherapy.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 31, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
February 1, 2025
Actual (reported)February 5, 2025
Actual (reported)February 18, 2025
Actual (reported)December 31, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
December 31, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Progression-free survival
Progression-free survival
2 years
overall survival
2 years
objective remission rate
2 years
Disease control rate
2 years
PTV1 was firstly treated with photon radiotherapy (started within 30 days after surgery), with a total dose of 50Gy for 25 times. After photon radiotherapy, PTV2 carbon ion radiotherapy was started, the total dose was 24.8Gy(RBE), 8 times. 3.1Gy(RBE)/fx; 1fx/ day, 5 days/week
PTV1 was first treated with photon radiotherapy (started within 30 days after surgery), with a total dose of 50Gy, 25 times; After photon radiotherapy, PTV2 carbon ion radiotherapy was started, the total dose was 24.8Gy(RBE), 8 times. 3.1Gy(RBE)/fx; 1fx/ day, 5 days/week.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Heavy Ion Radiotherapy Department
Wuwei, Gansu, 733000, China
Isono M, Yoshida Y, Takahashi A, Oike T, Shibata A, Kubota Y, Kanai T, Ohno T, Nakano T. Carbon-ion beams effectively induce growth inhibition and apoptosis in human neural stem cells compared with glioblastoma A172 cells. J Radiat Res. 2015 Sep;56(5):856-61. doi: 10.1093/jrr/rrv033. Epub 2015 Jun 11.
Adeberg S, Bernhardt D, Harrabi SB, Uhl M, Paul A, Bougatf N, Verma V, Unterberg A, Wick W, Haberer T, Combs SE, Herfarth K, Debus J, Rieken S. Sequential proton boost after standard chemoradiation for high-grade glioma. Radiother Oncol. 2017 Nov;125(2):266-272. doi: 10.1016/j.radonc.2017.09.040. Epub 2017 Oct 16.
Xiaojun Li
Gansu Wuwei Tumor Hospital
First Submitted
February 5, 2025
First Posted
February 18, 2025
Study Start
February 1, 2025
Actual (reported)Primary Completion
December 31, 2027
Study of Adaptive Radiotherapy for High-grade Glioma Based on Interfraction MRI
Contact the study team to confirm eligibility.
Mizoe JE, Tsujii H, Hasegawa A, Yanagi T, Takagi R, Kamada T, Tsuji H, Takakura K; Organizing Committee of the Central Nervous System Tumor Working Group. Phase I/II clinical trial of carbon ion radiotherapy for malignant gliomas: combined X-ray radiotherapy, chemotherapy, and carbon ion radiotherapy. Int J Radiat Oncol Biol Phys. 2007 Oct 1;69(2):390-6. doi: 10.1016/j.ijrobp.2007.03.003. Epub 2007 Apr 24.
Kong L, Wu J, Gao J, Qiu X, Yang J, Hu J, Hu W, Mao Y, Lu JJ. Particle radiation therapy in the management of malignant glioma: Early experience at the Shanghai Proton and Heavy Ion Center. Cancer. 2020 Jun 15;126(12):2802-2810. doi: 10.1002/cncr.32828. Epub 2020 Mar 13.
Hasegawa A, Mizoe JE, Tsujii H, Kamada T, Jingu K, Iwadate Y, Nakazato Y, Matsutani M, Takakura K; Organizing Committee of the Central Nervous System Tumor Working Group. Experience with carbon ion radiotherapy for WHO Grade 2 diffuse astrocytomas. Int J Radiat Oncol Biol Phys. 2012 May 1;83(1):100-6. doi: 10.1016/j.ijrobp.2011.06.1952. Epub 2011 Nov 19.
Pisapia DJ. The Updated World Health Organization Glioma Classification: Cellular and Molecular Origins of Adult Infiltrating Gliomas. Arch Pathol Lab Med. 2017 Dec;141(12):1633-1645. doi: 10.5858/arpa.2016-0493-RA.
Walker MD, Alexander E Jr, Hunt WE, MacCarty CS, Mahaley MS Jr, Mealey J Jr, Norrell HA, Owens G, Ransohoff J, Wilson CB, Gehan EA, Strike TA. Evaluation of BCNU and/or radiotherapy in the treatment of anaplastic gliomas. A cooperative clinical trial. J Neurosurg. 1978 Sep;49(3):333-43. doi: 10.3171/jns.1978.49.3.0333.
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.
Stupp R, Hegi ME, Mason WP, van den Bent MJ, Taphoorn MJ, Janzer RC, Ludwin SK, Allgeier A, Fisher B, Belanger K, Hau P, Brandes AA, Gijtenbeek J, Marosi C, Vecht CJ, Mokhtari K, Wesseling P, Villa S, Eisenhauer E, Gorlia T, Weller M, Lacombe D, Cairncross JG, Mirimanoff RO; European Organisation for Research and Treatment of Cancer Brain Tumour and Radiation Oncology Groups; National Cancer Institute of Canada Clinical Trials Group. Effects of radiotherapy with concomitant and adjuvant temozolomide versus radiotherapy alone on survival in glioblastoma in a randomised phase III study: 5-year analysis of the EORTC-NCIC trial. Lancet Oncol. 2009 May;10(5):459-66. doi: 10.1016/S1470-2045(09)70025-7. Epub 2009 Mar 9.
Hegi ME, Diserens AC, Gorlia T, Hamou MF, de Tribolet N, Weller M, Kros JM, Hainfellner JA, Mason W, Mariani L, Bromberg JE, Hau P, Mirimanoff RO, Cairncross JG, Janzer RC, Stupp R. MGMT gene silencing and benefit from temozolomide in glioblastoma. N Engl J Med. 2005 Mar 10;352(10):997-1003. doi: 10.1056/NEJMoa043331.
Gilbert MR, Wang M, Aldape KD, Stupp R, Hegi ME, Jaeckle KA, Armstrong TS, Wefel JS, Won M, Blumenthal DT, Mahajan A, Schultz CJ, Erridge S, Baumert B, Hopkins KI, Tzuk-Shina T, Brown PD, Chakravarti A, Curran WJ Jr, Mehta MP. Dose-dense temozolomide for newly diagnosed glioblastoma: a randomized phase III clinical trial. J Clin Oncol. 2013 Nov 10;31(32):4085-91. doi: 10.1200/JCO.2013.49.6968. Epub 2013 Oct 7.
Planned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
December 31, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
February 18, 2025
Record last verified: 2025-02
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Source: ClinicalTrials.gov.
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