Ultra-low Dose Bevacizumab Plus Temozolomide for Recurrent High-grade Gliomas

Not Applicable

• Conditions: Recurrent High-grade Glioma
• Interventions: Drug: Ultra-low dose Bevacizumab; Drug: Temozolomide

• Registration Number: NCT02416999
• Lead Sponsor: Hebei Yanda Hospital

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.

Study Timeline

• Study First Submitted: 2015-04-01
• Study First Submitted QC: 2015-04-10
• Study First Posted: 2015-04-15
• Study Start: 2015-05
• Status Verified: 2016-02
• Last Update Submitted: 2016-02-17
• Last Update Posted: 2016-02-18
• Primary Completion: 2018-05
• Study Completion: 2018-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
patient group	Ultra-low dose Bevacizumab	-
patient group	Temozolomide	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Progression free survival of recurrent glioblastoma multiforme patients under ultra-low dose Bevacizumab plus Temozolomide treatment	6 months or later, up to 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
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
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
Overall survival of recurrent glioblastoma multiforme patients under ultra-low dose Bevacizumab plus Temozolomide treatment	6 months or later, up to 12 months

Trial Locations

Locations (2)

Hebei Yanda Hospital; 🇨🇳 Sanhe, Hebei, China

Beijing Tiantan Hospital; 🇨🇳 Beijing, Beijing, China