NCT02416999

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2015

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 1, 2015

Completed
14 days until next milestone

First Posted

Study publicly available on registry

April 15, 2015

Completed
16 days until next milestone

Study Start

First participant enrolled

May 1, 2015

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2018

Completed
Last Updated

February 18, 2016

Status Verified

February 1, 2016

Enrollment Period

3 years

First QC Date

April 1, 2015

Last Update Submit

February 17, 2016

Conditions

Recurrent High-grade Glioma

Keywords

gliomahigh-grade glioma

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (6)

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

    6 months or later, up to 12 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 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

  • 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

  • +1 more secondary outcomes

Study Arms (1)

patient group

EXPERIMENTAL
Drug: Ultra-low dose BevacizumabDrug: Temozolomide

Interventions

Ultra-low dose BevacizumabDRUG
Also known as: BVZ
patient group
TemozolomideDRUG
Also known as: TMZ
patient group

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Beijing Tiantan Hospital

Beijing, Beijing Municipality, 100050, China

Location

Hebei Yanda Hospital

Sanhe, Hebei, 065200, China

Location

MeSH Terms

Conditions

Glioma

Interventions

Temozolomide

Condition Hierarchy (Ancestors)

Neoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Glandular and EpithelialNeoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

DacarbazineTriazenesOrganic ChemicalsImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Jisheng Wang, MD

    Beijing Tiantan Hospital

    PRINCIPAL INVESTIGATOR

  • Nan Ji, MD

    Beijing Tiantan Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Nan Ji, MD

CONTACT

+86 13910713896neurochina@gmail.com

Jisheng Wang, MD

CONTACT

+86 15210503095neurowang@sina.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 1, 2015

First Posted

April 15, 2015

Study Start

May 1, 2015

Primary Completion

May 1, 2018

Study Completion

May 1, 2018

Last Updated

February 18, 2016

Record last verified: 2016-02

Locations

CN(2)