Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
The investigators tend to make reference to the prescribed dose and segmentation method in the phase I/II clinical study program completed by Mizoe et al., NIRS. It is estimated that the 1-year OS rate of high-grade glioma treated with photon (50Gy divided into 25 times) followed by carbon ion push (24.8GyE divided into 8 times) can reach 87.8%, and the target value is set at 61.1%. A single-center, single-arm, prospective Phase II clinical trial was conducted to evaluate the safety and efficacy of this regimen. The primary end points were treatment-related toxicity, dose-restricted toxicity, and progression-free survival, while the secondary end points were survival and objective response rate. A safe and effective segmentation dose for high-grade glioma suitable for the investigators' facility and RBE model was obtained. Using the physical dosimetry and biological advantages of heavy ions, the investigators can improve the tumor control rate and reduce the occurrence of radiation damage in peripheral brain tissue caused by increasing prescription dose, and provide new treatment suggestions for glioma radiotherapy.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study group | Experimental | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Carbon ion combined with photon radiotherapy | Radiation | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival | Progression-free survival | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| overall survival | overall survival | 2 years |
| objective remission rate | objective remission rate | 2 years |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiaojun Li | Contact | +8613150160200 | anglweli@qq.com |
| Name | Affiliation | Role |
|---|---|---|
| Xiaojun Li | Gansu Wuwei Tumor Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Heavy Ion Radiotherapy Department | Recruiting | Wuwei | Gansu | 733000 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26070322 | Background | 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. | |
| 29050959 | Background |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D005910 | Glioma |
| ID | Term |
|---|---|
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
Not provided
Not provided
Carbon ion combined with photon radiotherapy
Not provided
Not provided
Not provided
Not provided
|
| Disease control rate | Disease control rate | 2 years |
| 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. |
| 17459607 | Background | 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. |
| 32167589 | Background | 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. |
| 22104357 | Background | 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. |
| 29189064 | Background | 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. |
| 355604 | Background | 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. |
| 15758009 | Background | 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. |
| 19269895 | Background | 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. |
| 15758010 | Background | 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. |
| 24101040 | Background | 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. |
| D009369 | Neoplasms |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |