Recurrent High-grade Glioma
Conditions
Keywords
glioma, high-grade glioma
Brief summary
This study is to evaluate the effectiveness of ultra-low dose Bevacizumab plus Temozolomide for recurrent high-grade gliomas.
Detailed description
This trial is aimed at evaluating the effectiveness of ultra-low dose Bevacizumab plus Temozolomide for recurrent high-grade gliomas. And, this trial is approved by medical ethics committee of Hebei Yanda Hospital.Researchers will conduct thsi trial from 2015/05 to 2018/05, and 30 recurrent high-grade glioma patients will be recruited. Patients who are recruited will get treatment of ultra-low dose Bevacizumab plus Temozolomide in ether Hebei Yanda Hospital or Beijing Tiantan hospital, and get follow-ups from clinicians.
Interventions
DRUGUltra-low dose Bevacizumab
DRUGTemozolomide
Sponsors
Beijing Tiantan Hospital
Hebei Yanda Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* High grade glioma was diagnosed by post-operation pathological method, and shows a relapse. * Before included, the patient needs imageological examinations, and the diameter of contrast enhancing area is bigger than 1cm, PET or MRS results show positive features. * The age of patient should be between 18 years old and 70 years old. * The condition of the patient permits the treatment of ultra-low dose Bevacizumab plus Temozolomide. * The patient is informed consent,and willing to join in this research.
Exclusion criteria
* The diagnosis is not recurrent high-grade glioma. * The diagnosis of high-grade glioma was not established by pathological method. * The results of imageological examinations do not meet the standard of including. * The age of the patient does not meet the requirement of this research. * The condition of the patient does not permit the treatment of ultra-low dose Bevacizumab plus Temozolomide. * There are other conditions that the clinicians believe that the treatment of ultra-low dose Bevacizumab plus Temozolomide is not appropriate for the patient. * The patient is not willing to join in this research.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 6-month survival rate of recurrent glioblastoma multiforme patients under ultra-low dose Bevacizumab plus Temozolomide treatment | 6 months |
| 12-month survival rate of recurrent WHO-III glioma patients under ultra-low dose Bevacizumab plus Temozolomide treatment | 12 months |
Secondary
| Measure | Time frame |
|---|---|
| Progression free survival of recurrent glioblastoma multiforme patients under ultra-low dose Bevacizumab plus Temozolomide treatment | 6 months or later, up to 12 months |
| Progression free survival of recurrent WHO-III glioma patients under ultra-low dose Bevacizumab plus Temozolomide treatment | 12 months or later, up to 24 months |
| Overall survival of recurrent glioblastoma multiforme patients under ultra-low dose Bevacizumab plus Temozolomide treatment | 6 months or later, up to 12 months |
| 12-month life quality as measured by European Organization for the Research and Treatment of Cancer Quality of Life questionnaires(EORTC QLQ-C30 and EORTC QLQ-BN20 together) | 12 months |
| 6-month life quality as measured by European Organization for the Research and Treatment of Cancer Quality of Life questionnaires(EORTC QLQ-C30 and EORTC QLQ-BN20 together) | 6 months |
| Overall survival of recurrent WHO-III glioma patients under ultra-low dose Bevacizumab plus Temozolomide treatment | 12 months or later, up to 24 months |
Countries
China
Contacts
Primary ContactNan Ji, MD
Backup ContactJisheng Wang, MD
Outcome results
None listed