Clinical trial NCT02416999: Ultra-low Dose Bevacizumab Plus Temozolomide for Recurrent High-grade Gliomas
Official title: Ultra-low Dose Bevacizumab Plus Temozolomide for Recurrent High-grade Gliomas
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Recurrent High-grade Glioma
Keywords: glioma
high-grade glioma
Lead sponsor: Hebei Yanda Hospital
Sponsor class: OTHER
Collaborators: name: Beijing Tiantan Hospital
First posted: 2015-04-15
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: 6-month survival rate of recurrent glioblastoma multiforme patients under ultra-low dose Bevacizumab plus Temozolomide treatment
timeFrame: 6 months
measure: 12-month survival rate of recurrent WHO-III glioma patients under ultra-low dose Bevacizumab plus Temozolomide treatment
timeFrame: 12 months
Secondary outcomes:
measure: Overall survival of recurrent glioblastoma multiforme patients under ultra-low dose Bevacizumab plus Temozolomide treatment
timeFrame: 6 months or later, up to 12 months
measure: Overall survival of recurrent WHO-III glioma patients under ultra-low dose Bevacizumab plus Temozolomide treatment
timeFrame: 12 months or later, up to 24 months
measure: Progression free survival of recurrent glioblastoma multiforme patients under ultra-low dose Bevacizumab plus Temozolomide treatment
timeFrame: 6 months or later, up to 12 months
measure: Progression free survival of recurrent WHO-III glioma patients under ultra-low dose Bevacizumab plus Temozolomide treatment
timeFrame: 12 months or later, up to 24 months
measure: 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)
timeFrame: 6 months
measure: 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)
timeFrame: 12 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Tiantan Hospital
state: Beijing
city: Sanhe
country: China
facility: Hebei Yanda Hospital
state: Hebei
Study officials:
affiliation: Beijing Tiantan Hospital
name: Jisheng Wang, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Beijing Tiantan Hospital
name: Nan Ji, MD
role: PRINCIPAL_INVESTIGATOR
References: