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New treatment option for Carbon Ion Radiotheray
Official title Clinical Study of Carbon Ion Radiotherapy for High-grade Glioma
ClinicalTrials.gov ID: NCT06831773
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 14 to 80
You may be able to join if
- 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...
- 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 treatment, photodynamic or other tumor ablation was...
- Can accept MRI and enhanced CT examination, and there are no metal artifacts in CTV;
You likely can't join if
- 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;
See the full eligibility criteria
Who can 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...
- 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 treatment, photodynamic or other tumor ablation was performed within 4 weeks before this radiotherapy; The operative wound has...
- 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);
- Liver function, kidney function and bone marrow function were basically normal (ALT and AST \ 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...
- 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.
What rules you out
- 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;
- 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...
- 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...
- Inability to understand the purpose of treatment or unwillingness/inability to sign treatment consent.
The study team makes the final eligibility decision.
Where it's taking place
- Wuwei, Gansu, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 14 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Wuwei, Gansu, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.