Glioma
Conditions
Interventions
experimental group:hyperbaric oxygen+radiotherapy+TMZ
control group:radiotherapy+TMZ
Sponsors
Chongqing general hospital
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1) Age 18-70 years old, gender unlimited; 2) Primary intracranial space occupying lesions, which were pathologically confirmed to be in line with WHO Guidelines for the diagnosis and Treatment of brain glioma (2021 edition) and diagnosed as glioma (WHO Grade 4; IDH1 wild type), as determined by a third-party expert panel of non-project participants; 3) Endoscopic total resection of intraoperative space-occupying lesions, postoperative head MRI showed total resection of intracranial space-occupying lesions, and the final judgment was made by a third-party expert panel of non-participants; 4) To be included, women must meet the following conditions: there is no possibility of pregnancy and consent to complete pregnancy during the study period Contraception, and for at least 6 months after completion of the study or early termination of the study; 5) The patient has signed the informed consent, promised to comply with the study procedures, and cooperate with the implementation of the whole process of the study; 6) Agree not to participate in other clinical studies.
Exclusion criteria
Exclusion criteria: 1) Allergic constitution, with a history of related allergies, especially a history of drug use allergies; 2) Patients with any other diseases that are not suitable for hyperbaric oxygen, radiation therapy, or chemotherapy treatment, or patients with a total radiation dose below 54 Gy; 3) Any other existing diseases, such as severe anemia, require medication that may affect the absorption of temozolomide in patients; 4) Contraindications for cranial enhanced MRI or other examinations, such as hypersensitivity to contrast agents; 5) Uncontrolled systemic diseases, including but not limited to: patients with short-term life-threatening conditions such as kidney, liver, or heart failure; 6) Uncontrolled major mental illnesses, including but not limited to depressive symptoms (CESD-R scale = 16); 7) Patients whose minds are affected and unable to complete neurological function assessments; 8) Pregnant and lactating women; 9) Those who have undergone other relevant clinical studies within the first three months; 10) Postoperative serious complications may endanger life or be in a vegetative state at any time; 11) Past or present combined with other parts or systemic tumor lesions; 12) Patients with poor compliance and inability to strictly follow the plan; 13) Substance use disorders (according to DSM-V standards, including drug or alcohol addiction, etc.); 14) Other serious situations that may hinder clinical research.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| side reaction;adverse event ;Neurological examination/clinical symptom monitoring; | — |
Secondary
| Measure | Time frame |
|---|---|
| KPS score;Common neurological function scores;Dynamic improvement of brain enhanced MRI in evaluating intracranial lesions;Disease free survival and overall survival; | — |
Countries
China
Contacts
Public ContactNan Wu
Chongqing general hospital
Outcome results
None listed