About this trial
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
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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;
Trial design
Single group
Treatments tested in this trial
Carbon ion combined with photon radiotherapy
RadiationPTV1 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.
Treatment groups
Trial outcomes
Primary outcomes
Progression-free survival
Progression-free survival
Secondary outcomes
overall survival
overall survival
objective remission rate
objective remission rate
Disease control rate
Disease control rate
Sponsors and contacts
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