Using carbon ion radiotherapy to treat high-grade glioma

Phase II Clinical Study of Carbon Ion Combined with Photon Radiotherapy for High-grade Glioma

This study is testing a new type of radiation therapy using carbon ions combined with regular radiation to see if it can help people with high-grade glioma live longer and have fewer side effects.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 23 (estimated)
• Ages: 14 Years to 80 Years
• Sex: All
• Sponsor: Gansu Wuwei Tumor Hospital (other)
• Drugs / interventions: radiation
• Locations: 1 site (Wuwei, Gansu)
• Trial ID: NCT06831773 on ClinicalTrials.gov

What this trial studies

This clinical study aims to improve tumor control and long-term survival rates for patients with high-grade glioma by utilizing carbon ion radiotherapy combined with photon radiotherapy. The approach is based on the advantages of heavy ion physical dosimetry and biology, which may reduce radiation damage to surrounding brain tissue while effectively targeting the tumor. The study will evaluate treatment-related toxicity, dose-restricted toxicity, and progression-free survival, with a focus on achieving a significant one-year overall survival rate. This single-center, single-arm trial will provide new insights into effective treatment strategies for glioma radiotherapy.

Who should consider this trial

Good fit: Ideal candidates include individuals aged 14 to 80 with IDH wild-type or mutant high-grade gliomas, including glioblastoma and anaplastic astrocytomas.

Not a fit: Patients with distant or intraspinal metastasis or those with multiple intracranial lesions may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve survival rates and reduce side effects for patients with high-grade glioma.

How similar studies have performed: While this approach is based on previous studies, it is exploring a novel application of carbon ion therapy specifically for high-grade glioma.

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.

Where this trial is running

Wuwei, Gansu

• Heavy Ion Radiotherapy Department — Wuwei, Gansu, China (RECRUITING)

Study contacts

• Study coordinator: Xiaojun Li

Conditions: Carbon Ion Radiotheray, High-grade Glioma, Heavy Ion Radiotherapy