newly-diagnosed glioblastoma
Conditions
Interventions
Control group: Standard photon radiation (60Gy)
Sponsors
Wuwei Tumor Hospital Heavy Ion Center
Eligibility
Sex/Gender
All
Age
14 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Age =14 years and =80 years; 2. Indication: According to the criteria of the fifth edition of WHO Classification of Central nervous System Tumors published in 2021, the histological characteristics and molecular phenotypes were integrated. The molecular phenotypes were IDH wild-type glioma and IDH mutant WHO grade ? and ? glioma. They mainly included: IDH wild-type low-grade glioma (grade 4 astrocytoma defined by the 2021 WHO classification); Anaplastic Astrocytoma, AA; Anaplastic Oligodendroglioma, AOG; Anaplastic Oligoastrocytoma, AOA; Glioblastoma Multiforme, GBM. Regardless of the degree of completeness of the procedure, that is, after total, subtotal, or partial resection, and after stereotactic or craniotomy biopsy. 3. No distant or intraspinal dissemination and metastasis; Single or two intracranial lesions may be covered by the same radiotherapy plan. 4. The treatment before radiotherapy was as follows: Initial radiotherapy: no interventional, photodynamic or other tumor ablation was performed within 4 weeks before radiotherapy; The surgical wound has healed completely. 5. MRI and enhanced CT examination can be accepted, and no metal artifacts in CTV; 6. No history of other malignant tumors (except cured skin cancer and stage 0 cervical cancer); 7. Liver function, renal 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;) 8. Good physical condition, i.e. ECOG (Eastern Oncology Collaborative Group) 0~2; There were no comorbidities such as severe pulmonary hypertension, cardiovascular disease, peripheral vascular disease, or severe chronic heart disease that might affect radiotherapy. Cardiac function grade 1. 9. Adequate major organ function according to the New York College of Cardiology Classification (NYHA); 10. Predicted survival (after treatment) =6 months; 11. Prior to radiotherapy, the patient or his or her legal representative had signed informed consent.
Exclusion criteria
Exclusion criteria: 1. Whoii-iv grade glioma not confirmed by pathology; 2. Patients who cannot lie still for 30 minutes; 4. Distant metastasis, or scattered or multiple (>2) intracranial lesions; 5. Received conventional photon/proton/carbon ion radiotherapy to the head; 6. Had undergone intracranial radioactive particle implantation, and implants with metal prostheses may affect the dose of particle radiotherapy; 7. With claustrophobia, pacemaker or metal prosthesis implant, unable to undergo MRI examination; 8. Cardiac pacemakers or other metal prosthesis implants that may be subject to interference with normal function by high-energy radiation or that may affect the dose to the radiation target; 9. The dose limit of organs at risk cannot reach the preset safe dose limit; 10. Pregnancy (confirmed by serum or urine ß-hCG test) or lactation period; 11. Lose more than 20% of body weight within six months; 12. People living with AIDS, including those who have received antiretroviral therapy; Active stage of syphilis; 13. There are serious comorbidities that prevent the trial protocol from being carried out, including uncontrolled systemic or co-morbidities (pulmonary insufficiency, cardiovascular, pulmonary, hepatic, renal, diabetes, etc.), drug or alcohol abuse, addiction, and/or mental illness; 14. Patients with poor compliance, including the possibility of not completing the treatment plan or failing to receive prescribed follow-up and examinations; 15. History of other malignant tumors (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 trial; 18. Having no or limited capacity for civil conduct; 19. Any medical history that, in the investigator's judgment, may interfere with the trial results or increase the patient's risk; 20. Any situation in which the physician did not consider it appropriate to participate in the trial, in which the physician determined that the patient would not benefit from carbon-ion radiotherapy, or in which there were other medical conditions or other factors that might affect carbon-ion therapy. Unable to understand the purpose of treatment or unwilling/unable to sign consent for treatment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall survival at 18 months;side-effect; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-free survival;objective remission rate; | — |
Countries
China
Contacts
Public ContactXiaojun Li
Gansu Wuwei Tumor Hospital
Outcome results
None listed