Carbon-ion beams effectively induce growth inhibition and apoptosis in human neural stem cells compared with glioblastoma A172 cells.
Mayu Isono, Yukari Yoshida, Akihisa Takahashi...
https://pubmed.ncbi.nlm.nih.gov/26070322Actively Recruiting
Phase Not Applicable
Age: 14Years - 80Years
All Genders
ID06831773
Phase II Clinical Study of Carbon Ion Combined with Photon Radiotherapy for High-grade Glioma
Led by Gansu Wuwei Tumor Hospital · Updated on 2025-02-18
23
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating carbon ion combined with photon radiotherapy as a treatment for high-grade glioma, a type of brain tumor. This study aims to improve tumor control and long-term survival while reducing brain tissue damage caused by radiation. The trial builds on earlier clinical programs and seeks to find safe and effective dosing for this therapy. Participants first receive photon radiotherapy shortly after surgery, with a total dose of 50 Gy divided into 25 sessions. After completing photon treatment, they receive carbon ion radiotherapy targeting the tumor area with a total dose of 24.8 Gy (RBE) over 8 sessions, delivered once daily, five days a week. This phase II clinical trial is single-center, single-arm, and prospective, focusing on the safety and efficacy of this combined treatment. Throughout the study, participants undergo regular MRI and enhanced CT scans to monitor tumor response and brain tissue health. Researchers assess treatment-related toxicity, progression-free survival over two years, overall survival, objective remission, and disease control. The study includes evaluations of organ function and physical condition and lasts for at least two years of follow-up to measure outcomes and safety.
CONDITIONS
Brief Title
Clinical Study of Carbon Ion Radiotherapy for High-grade Glioma
Who Can Participate
Age: 14Years - 80Years
All Genders
Eligibility Criteria
You may qualify if you...
- Age 14 years and older but not more than 80 years
- Diagnosis of high-grade glioma according to 2021 WHO CNS Tumor Classification, including IDH wild-type and mutant types
- Single or two intracranial lesions without distant or intraspinal spread
- No interventional or tumor ablation treatments within 4 weeks before radiotherapy
- Operative wound fully healed before treatment
- Able to undergo MRI and enhanced CT without metal artifacts
- No history of other malignant tumors except cured skin cancer and stage 0 cervical cancer
- Normal liver, kidney, and bone marrow function within defined laboratory limits
- Good physical condition with ECOG score 0 to 2 and no severe cardiopulmonary complications
- Adequate function of major organs
- Predicted survival of at least 6 months
- Signed informed consent before radiotherapy
You will not qualify if you...
- Unconfirmed WHO II-IV glioma by pathology
- Unable to lie still for 30 minutes
- Receiving secondary treatment for recurrent tumors
- Presence of distant metastases or more than two intracranial lesions
- Previous head radiotherapy including photon, proton, or carbon ion
- Intracranial radioactive particle implantation with metal implants
- Unable to receive MRI due to claustrophobia, pacemaker, or metal implants
- Pacemakers or metal implants interfering with radiation or target dosing
- Organs at risk cannot meet safe dose limits
- Pregnancy or lactation
- Weight loss over 20% in last 6 months
- AIDS or active syphilis
- Serious uncontrolled comorbidities or substance abuse
- Poor compliance or inability to complete treatment and follow-up
- Participation in other drug trials within 30 days
- Limited legal capacity or inability to consent
- Medical conditions that increase risk or interfere with trial
- Contraindications to radiotherapy
- Unwillingness or inability to understand or sign consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Approximately 7 weeks
Participants receive photon radiotherapy first, followed by carbon ion radiotherapy targeting high-grade glioma.
33 visits (25 photon radiotherapy sessions and 8 carbon ion radiotherapy sessions, 1 session per day, 5 days per week)
Follow-up
Duration - Up to 2 years
Participants are monitored for treatment-related toxicity, disease progression, and survival outcomes.
Regular follow-up visits during 2 years
Trial Site Locations
Total: 1 location
1
Heavy Ion Radiotherapy Department
Wuwei, Gansu, China, 733000
Actively Recruiting
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Research Team
X
Xiaojun Li
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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Published Research Related To This Trial
Sequential proton boost after standard chemoradiation for high-grade glioma.
Sebastian Adeberg, Denise Bernhardt, Semi Ben Harrabi...
https://pubmed.ncbi.nlm.nih.gov/29050959Phase I/II clinical trial of carbon ion radiotherapy for malignant gliomas: combined X-ray radiotherapy, chemotherapy, and carbon ion radiotherapy.
Jun-Etsu Mizoe, Hirohiko Tsujii, Azusa Hasegawa...
https://pubmed.ncbi.nlm.nih.gov/17459607Particle radiation therapy in the management of malignant glioma: Early experience at the Shanghai Proton and Heavy Ion Center.
Lin Kong, Jinsong Wu, Jing Gao...
https://pubmed.ncbi.nlm.nih.gov/32167589Experience with carbon ion radiotherapy for WHO Grade 2 diffuse astrocytomas.
Azusa Hasegawa, Jun-Etsu Mizoe, Hirohiko Tsujii...
https://pubmed.ncbi.nlm.nih.gov/22104357The Updated World Health Organization Glioma Classification: Cellular and Molecular Origins of Adult Infiltrating Gliomas.
David J Pisapia
https://pubmed.ncbi.nlm.nih.gov/29189064Evaluation of BCNU and/or radiotherapy in the treatment of anaplastic gliomas. A cooperative clinical trial.
M D Walker, E Alexander, W E Hunt...
https://pubmed.ncbi.nlm.nih.gov/355604Radiotherapy plus concomitant and adjuvant temozolomide for glioblastoma.
Roger Stupp, Warren P Mason, Martin J van den Bent...
https://pubmed.ncbi.nlm.nih.gov/15758009Effects 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.
Roger Stupp, Monika E Hegi, Warren P Mason...
https://pubmed.ncbi.nlm.nih.gov/19269895MGMT gene silencing and benefit from temozolomide in glioblastoma.
Monika E Hegi, Annie-Claire Diserens, Thierry Gorlia...
https://pubmed.ncbi.nlm.nih.gov/15758010