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Status unknownNCT02416999Updated Feb 18, 2016

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

An interventional study of Ultra-low dose Bevacizumab and Temozolomide in Recurrent High-grade Glioma, sponsored by Hebei Yanda Hospital. Status unknown at 2 sites in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2016-02-18.

Sponsored by Hebei Yanda Hospital · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Feb 2016), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Not applicable
Ages
18 Years to 70 Years
Sex
All
01

Study summary

This study is to evaluate the effectiveness of ultra-low dose Bevacizumab plus Temozolomide for recurrent high-grade gliomas.

Read the 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.

02

Conditions studied

  • Recurrent High-grade Glioma

Keywords

  • glioma
  • high-grade glioma
03

In context

Glioma

1,397 studies on the registry are indexed under Glioma; 351 are open to participants now.

This study's planned enrollment of 30 is close to the median of 32 across 1,065 interventional studies indexed under Glioma.

Browse Glioma studies →

Lead sponsor

Hebei Yanda Hospital is the lead sponsor of 3 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts 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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
30 participants (estimated)

Study arms

  • Experimental
    patient group

    Drug: Ultra-low dose Bevacizumab · Drug: Temozolomide

Interventions

  • DrugUltra-low dose Bevacizumab

    Also known as: BVZ

  • DrugTemozolomide

    Also known as: TMZ

06

What researchers measure

Primary outcomes

  1. 6-month survival rate of recurrent glioblastoma multiforme patients under ultra-low dose Bevacizumab plus Temozolomide treatment

    Time frame: 6 months

  2. 12-month survival rate of recurrent WHO-III glioma patients under ultra-low dose Bevacizumab plus Temozolomide treatment

    Time frame: 12 months

Secondary outcomes

  1. Overall survival of recurrent glioblastoma multiforme patients under ultra-low dose Bevacizumab plus Temozolomide treatment

    Time frame: 6 months or later, up to 12 months

  2. Overall survival of recurrent WHO-III glioma patients under ultra-low dose Bevacizumab plus Temozolomide treatment

    Time frame: 12 months or later, up to 24 months

  3. Progression free survival of recurrent glioblastoma multiforme patients under ultra-low dose Bevacizumab plus Temozolomide treatment

    Time frame: 6 months or later, up to 12 months

  4. Progression free survival of recurrent WHO-III glioma patients under ultra-low dose Bevacizumab plus Temozolomide treatment

    Time frame: 12 months or later, up to 24 months

  5. 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)

    Time frame: 6 months

  6. 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)

    Time frame: 12 months

07

Study locations

2 sites
  • Beijing Tiantan Hospital
    Beijing, Beijing 100050, China
    • Nan Ji, MD · Contact · neurochina@gmail.com · +86 13910713896
    • Jisheng Wang, MD · Principal investigator
    • Nan Ji, MD · Principal investigator
  • Hebei Yanda Hospital
    Sanhe, Hebei 065200, China
    • Nan Ji, MD · Contact · neurochina@gmail.com · +86 13910713896
    • Jisheng Wang, MD · Principal investigator
    • Nan Ji, MD · Principal investigator
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 18, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02416999
Lead sponsor
Hebei Yanda Hospital
Collaborators
Beijing Tiantan Hospital
Responsible party
Sponsor
First posted
Apr 15, 2015
Start date
May 2015
Primary completion
May 2018 (estimated)
Completion
May 2018 (estimated)
Last update
Feb 18, 2016

Study contacts

Nan Ji, MD
Contact
neurochina@gmail.com
+86 13910713896
Jisheng Wang, MD
Contact
neurowang@sina.com
+86 15210503095
Jisheng Wang, MD
principal investigator · Beijing Tiantan Hospital
Nan Ji, MD
principal investigator · Beijing Tiantan Hospital

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Feb 2016. You cannot join it, but the record below documents what was studied.

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