Status:
UNKNOWN
Neoadjuvant Temozolomide Combined With Simultaneous IMRT for Treatment of Glioblastoma
Lead Sponsor:
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Conditions:
Glioblastoma
Eligibility:
All Genders
18-70 years
Phase:
PHASE3
Brief Summary
This study is a prospective, multi-center, randomized controlled clinical study. Indications: Glioblastoma diagnosed after surgery (WHO grade IV). The patient received conventional postoperative concu...
Eligibility Criteria
Inclusion
- Age: 18 to 70 years old
- A patient with high-grade (WHO grade IV) glioma diagnosed pathologically
- ECOG score ≤ 3 points
- The expected survival time is greater than 3 months
- Patients undergoing surgery for the first time
- Patients who have not received radiotherapy at the treatment site in the past
- The following hematological indicators need to be met Neutrophil count ≥1.5×109/L Hemoglobin ≥9g/dL Platelet count ≥70×109/L
- The following biochemical indicators need to be met Total bilirubin≤1.5×upper limit of normal (ULN) AST and ALT\<1.5×ULN Creatinine clearance rate ≥60ml/min
- Patients of childbearing age need to take appropriate protective measures (contraception or other methods of birth control) before enrollment and during the trial
- The signed informed consent form
- Ability to follow research protocols and follow-up procedures
Exclusion
- Patients with recurrent glioma who have previously undergone surgery or radiotherapy and chemotherapy
- Glioma of the spinal cord
- ECOG score\> 3 points
- Severe mental symptoms; uncontrollable status epilepticus
- Patients with malignant tumors in other parts
- The patient has an active bacterial, viral or fungal infection (≥ Grade 2 NCI-CTC, 4th edition)
- The patient has severe liver and kidney dysfunction, HIV infection, HCV infection, uncontrollable coronary artery disease or asthma, uncontrollable cerebrovascular disease or other diseases that the researcher thinks cannot be included in the group
- Pregnant and lactating women. Women of childbearing age must have a negative pregnancy test within 7 days before joining the group
- Drug abuse, clinical, psychological or social factors affect informed consent or research implementation
- Any uncertain factors that affect the safety or compliance of patients
Key Trial Info
Start Date :
November 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2023
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT04829097
Start Date
November 1 2020
End Date
November 1 2023
Last Update
April 2 2021
Active Locations (1)
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1
The Affiliated Hospital of Nanjing University Medical School
Nanjing, Jiangsu, China, 210008