NCT06831773 Clinical Study of Carbon Ion Radiotherapy for High-grade Glioma
| NCT ID | NCT06831773 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Gansu Wuwei Tumor Hospital |
| Condition | Carbon Ion Radiotheray |
| Study Type | INTERVENTIONAL |
| Enrollment | 23 participants |
| Start Date | 2025-02-01 |
| Primary Completion | 2027-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 23 participants in total. It began in 2025-02-01 with a primary completion date of 2027-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 radiotherapy.
Eligibility Criteria
Inclusion Criteria: 1. Age ≥14 years and ≤80 years; 2. 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. 3. No distant or intraspinal spread and metastasis; A single or two intracranial lesions may be covered by the same radiotherapy plan. 4. 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. 5. Can accept MRI and enhanced CT examination, and there are no metal artifacts in CTV; 6. No history of other malignant tumors (except cured skin cancer and stage 0 cervical cancer); 7. 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;) 8. 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) 9. Adequate functions of major organs; 10. Predicted survival (after treatment) ≥6 months; 11. Informed consent has been signed by the patient or his legal representative before radiotherapy. Exclusion Criteria: 1. WHOII-IV glioma unconfirmed by pathology; 2. Patients who cannot lie still for 30 minutes; 3. Secondary treatment of recurrent tumors 4. There have been distant metastases, or scattered or multiple (\>2) intracranial lesions; 5. Have received conventional photon/proton/carbon ion radiotherapy to the head; 6. Have received intracranial radioactive particle implantation with metal implants that may affect the dose of particle radiation therapy; 7. Unable to receive MRI with claustrophobia or a pacemaker or metal implant 8. Pacemakers or other metal implants that may be interfered with normal function by high-energy radiation or may affect the dose of radiation target; 9. The dose limit for organs at risk cannot reach the preset safe dose limit 10. Pregnancy (confirmed by serum or urine β-HCG test) or lactation 11. losing more than 20% of your body weight within six months; 12. Persons with AIDS, including those who have received antiretroviral therapy; Active stage of syphilis; 13. 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; 14. Patients with poor compliance, including those who may not be able to complete the treatment plan or receive prescribed follow-up and examination; 15. have had other malignant neoplasms (except cured skin cancer and stage 0 cervical cancer); 16. There are contraindications to radiotherapy; 17. Participated in other drug clinical trials within 30 days prior to enrollment in this study; 18. having no or limited capacity for civil conduct; 19. Any medical history that, in the investigator's judgment, might interfere with the trial results or increase the patient's risk; 20. 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. 21. Inability to understand the purpose of treatment or unwillingness/inability to sign treatment consent.
Contact & Investigator
Xiaojun Li
STUDY DIRECTOR
Gansu Wuwei Tumor Hospital
Frequently Asked Questions
Who can join the NCT06831773 clinical trial?
This trial is open to participants of all sexes, aged 14 Years or older, up to 80 Years, studying Carbon Ion Radiotheray. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06831773 currently recruiting?
Yes, NCT06831773 is actively recruiting participants. Contact the research team at anglweli@qq.com for enrollment information.
Where is the NCT06831773 trial being conducted?
This trial is being conducted at Wuwei, China.
Who is sponsoring the NCT06831773 clinical trial?
NCT06831773 is sponsored by Gansu Wuwei Tumor Hospital. The principal investigator is Xiaojun Li at Gansu Wuwei Tumor Hospital. The trial plans to enroll 23 participants.