Carbon Ion RadiotherayNCT06831773
Clinical Study of Carbon Ion Radiotherapy for High-grade Glioma
A study testing Carbon ion combined with photon radiotherapy in people with Carbon Ion Radiotheray and High-grade Glioma, run by Gansu Wuwei Tumor Hospital at 1 site in China.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 14 to 80 years
- Conditions the study is for
- Carbon Ion Radiotheray, High-grade Glioma, Heavy Ion Radiotherapy
- What is being tested?
- Carbon ion combined with photon radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2025to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 14 to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Age ≥14 years and ≤80 years;
- Indications: According to the criteria of the 5th edition of WHO Classification of Central Nervous System Tumors published in 2021, histological characteristics and molecular phenotype were integrated, and the molecular phenotype was IDH wild-type glioma and IDH mutant WHO Grade Ⅲ and Ⅳ glioma. They mainly include: IDH wild-type low-grade glioma (Grade 4 astrocytoma according to the 2021 WHO classification definition); Anaplastic Astrocytoma, AA; anaplastic astrocytoma, AA; Anaplastic Oligodendroglioma, AOG; anaplastic oligodendroglioma, AOG; Anaplastic Oligoastrocytoma, AOA; anaplastic oligoastrocytoma, AOA; Glioblastoma Multiforme, GBM. Regardless of surgical completeness, i.e. after total, subtotal, or partial resection, and after stereotactic or craniotomy.
- No distant or intraspinal spread and metastasis; A single or two intracranial lesions may be covered by the same radiotherapy plan.
- The treatment conditions before this radiotherapy were as follows: First radiotherapy: no interventional, photodynamic or other tumor ablation was performed within 4 weeks before this radiotherapy; The operative wound has fully healed.
- Can accept MRI and enhanced CT examination, and there are no metal artifacts in CTV;
- No history of other malignant tumors (except cured skin cancer and stage 0 cervical cancer);
Show all 11Show fewer
- Liver function, kidney function and bone marrow function were basically normal (ALT and AST < 1.5 times of high normal value (ULN), bilirubin < 1.5×ULN; Adult endogenous creatinine clearance rate of 60ml/min or serum creatinine SCR≤140μmoI/L, BUN≤6.8mmol/L; Hemoglobin level >9 g/dL; White blood cell count ≥3.0*109/L; Platelet count ≥100*109/L;)
- Good physical condition, i.e. ECOG (Eastern United States Oncology Collaboration Group) 0~2; There were no complications such as severe pulmonary hypertension, cardiovascular disease, peripheral vascular disease, and severe chronic heart disease that may affect radiotherapy. Cardiac function grade 1. (According to the New York College of Cardiology Cardiac Function Scale (NYHA)
- Adequate functions of major organs;
- Predicted survival (after treatment) ≥6 months;
- Informed consent has been signed by the patient or his legal representative before radiotherapy.
Who cannot join
- WHOII-IV glioma unconfirmed by pathology;
- Patients who cannot lie still for 30 minutes;
- Secondary treatment of recurrent tumors
- There have been distant metastases, or scattered or multiple (>2) intracranial lesions;
- Have received conventional photon/proton/carbon ion radiotherapy to the head;
- Have received intracranial radioactive particle implantation with metal implants that may affect the dose of particle radiation therapy;
Show all 21Show fewer
- Unable to receive MRI with claustrophobia or a pacemaker or metal implant
- Pacemakers or other metal implants that may be interfered with normal function by high-energy radiation or may affect the dose of radiation target;
- The dose limit for organs at risk cannot reach the preset safe dose limit
- Pregnancy (confirmed by serum or urine β-HCG test) or lactation
- losing more than 20% of your body weight within six months;
- Persons with AIDS, including those who have received antiretroviral therapy; Active stage of syphilis;
- Accompanied by serious comorbiditions, including uncontrolled systemic or co-existing diseases (pulmonary insufficiency, cardiovascular, pulmonary, liver, kidney, diabetes, etc.), drug or alcohol abuse, dependence, addiction, and/or mental illness that prevent the successful implementation of the trial protocol;
- Patients with poor compliance, including those who may not be able to complete the treatment plan or receive prescribed follow-up and examination;
- have had other malignant neoplasms (except cured skin cancer and stage 0 cervical cancer);
- There are contraindications to radiotherapy;
- Participated in other drug clinical trials within 30 days prior to enrollment in this study;
- having no or limited capacity for civil conduct;
- Any medical history that, in the investigator's judgment, might interfere with the trial results or increase the patient's risk;
- Any condition in which the physician considers that participation in the trial is not appropriate, the physician determines that the patient will not benefit from carbon ion radiotherapy, or that there are other co-existing conditions or other factors that may affect carbon ion therapy.
- Inability to understand the purpose of treatment or unwillingness/inability to sign treatment consent.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Heavy Ion Radiotherapy Department
Wuwei, Gansu, 733000
Xiaojun Li, +8613150160200, anglweli@qq.com
About this study
Official title: Phase II Clinical Study of Carbon Ion Combined with Photon Radiotherapy for High-grade Glioma
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.
Read the detailed description
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.
- Being tested
- Carbon ion combined with photon radiotherapy
- Medical subject headings
- Glioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Carbon ion combined with photon radiotherapyRadiation
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Radiation: Carbon ion combined with photon radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival
Progression-free survival
Measured: 2 years
Secondary outcomes (3)
overall survival
overall survival
Measured: 2 years
objective remission rate
objective remission rate
Measured: 2 years
Disease control rate
Disease control rate
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2025
- Study start1 Feb 2025
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Carbon Ion RadiotherayStudies 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
- Model description
- Carbon ion combined with photon radiotherapy
- Masking
- None (open label)
- Enrolment
- 23 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gansu Wuwei Tumor Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Xiaojun Li, Study director, Gansu Wuwei Tumor Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06831773
- Sponsor's protocol ID
- 185647
- Status last verified
- Feb 2025
- First submitted
- 5 Feb 2025
- Last updated
- 18 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 26070322Adeberg 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.
PubMed 29050959Mizoe 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.
PubMed 17459607Kong 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.
PubMed 32167589Hasegawa 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.
PubMed 22104357Pisapia 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.
PubMed 29189064Walker 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.
PubMed 355604Stupp 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.
PubMed 15758009Stupp 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.
PubMed 19269895Hegi 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.
PubMed 15758010Gilbert 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.
PubMed 24101040
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Clinical Study of Carbon Ion Combined with Photon Radiotherapy for High-grade Glioma
- ClinicalTrials.gov ID
- NCT06831773
- Acronym / sponsor ID
- 185647
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 23 participants (estimated)
- Lead sponsor
- Gansu Wuwei Tumor HospitalUniversity, hospital or other
- Study start
- 1 Feb 2025 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 18 Feb 2025 (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 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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Carbon ion combined with photon radiotherapy
| Arm | Type | Receives |
|---|---|---|
| Study group | Experimental | Radiation: Carbon ion combined with photon radiotherapyPTV1 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 |
Who may qualify
- Ages
- 14 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (11 listed)
- Age ≥14 years and ≤80 years;
- Indications: According to the criteria of the 5th edition of WHO Classification of Central Nervous System Tumors published in 2021, histological characteristics and molecular phenotype were integrated, and the molecular phenotype was IDH wild-type glioma and IDH mutant WHO Grade Ⅲ and Ⅳ glioma. They mainly include: IDH wild-type low-grade glioma (Grade 4 astrocytoma according to the 2021 WHO classification definition); Anaplastic Astrocytoma, AA; anaplastic astrocytoma, AA; Anaplastic Oligodendroglioma, AOG; anaplastic oligodendroglioma, AOG; Anaplastic Oligoastrocytoma, AOA; anaplastic oligoastrocytoma, AOA; Glioblastoma Multiforme, GBM. Regardless of surgical completeness, i.e. after total, subtotal, or partial resection, and after stereotactic or craniotomy.
- No distant or intraspinal spread and metastasis; A single or two intracranial lesions may be covered by the same radiotherapy plan.
- The treatment conditions before this radiotherapy were as follows: First radiotherapy: no interventional, photodynamic or other tumor ablation was performed within 4 weeks before this radiotherapy; The operative wound has fully healed.
- Can accept MRI and enhanced CT examination, and there are no metal artifacts in CTV;
Key exclusion criteria (21 listed)
- WHOII-IV glioma unconfirmed by pathology;
- Patients who cannot lie still for 30 minutes;
- Secondary treatment of recurrent tumors
- There have been distant metastases, or scattered or multiple (>2) intracranial lesions;
- Have received conventional photon/proton/carbon ion radiotherapy to the head;
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 |
|---|---|---|
| Carbon ion combined with photon radiotherapyPTV1 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. | Radiation | Study group |
Primary outcome
Progression-free survival
Time frame: 2 years
Progression-free survival
3 secondary outcomes
overall survival
Time frame: 2 years
objective remission rate
Time frame: 2 years
Disease control rate
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2025.
- Background: PubMed 26070322Isono 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.
- Background: PubMed 29050959Adeberg 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.
- Background: PubMed 17459607Mizoe 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.
- Background: PubMed 32167589Kong 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.
- Background: PubMed 22104357Hasegawa 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.
- Background: PubMed 29189064Pisapia 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.
- Background: PubMed 355604Walker 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.
- Background: PubMed 15758009Stupp 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.
- Background: PubMed 19269895Stupp 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.
- Background: PubMed 15758010Hegi 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.
- Background: PubMed 24101040Gilbert 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.
- Individual participant dataSharing planned: No
Related trials for Carbon Ion Radiotheray
Recruiting
Phase I Study of Carbon-Ion Lattice Radiotherapy for Large Thoracic Tumors
Carbon Ion Radiotheray
Not yet recruitingObservational study
Efficacy and Safety of Chemoimmunotherapy and Carbon Ion Radiotherapy in Unresectable Locally Advanced Non-small Cell Lung Cancer
Carbon Ion Radiotheray
RecruitingPhase 2
Clinical Study of Postoperative Carbon Ion Radiotherapy for Thymus Tumor With Residual Tumor
Thymic Epithelial Tumor, Radiotherapy Side Effect
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.
Xiaojun Li study director
Gansu Wuwei Tumor Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Carbon ion combined with photon radiotherapy in people with Carbon Ion Radiotheray and High-grade Glioma, run by Gansu Wuwei Tumor Hospital at 1 site in China.
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 11 inclusion and 21 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: looking for participants now, as of the sponsor's last update on 18 Feb 2025. 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 China. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xiaojun Li (+8613150160200, anglweli@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival (time frame: 2 years). 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 NCT06831773, which also lists 11 linked publications.
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 18 Feb 2025.