Recurrent High-grade GliomaNCT02416999
Ultra-low Dose Bevacizumab Plus Temozolomide for Recurrent High-grade Gliomas
A study testing Ultra-low dose Bevacizumab and Temozolomide in people with Recurrent High-grade Glioma, run by Hebei Yanda Hospital at 2 sites in China.
Trial summary
This study is to evaluate the effectiveness of ultra-low dose Bevacizumab plus Temozolomide for recurrent high-grade gliomas. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Recurrent High-grade Glioma
- What is being tested?
- Ultra-low dose Bevacizumab and Temozolomide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesChina
- Study dates
- May 2015to May 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
China2 sites
Beijing Tiantan Hospital
Beijing, Beijing Municipality, 100050
Nan Ji, MD, +86 13910713896, neurochina@gmail.com
Jisheng Wang, MD
Hebei Yanda Hospital
Sanhe, Hebei, 065200
Nan Ji, MD, +86 13910713896, neurochina@gmail.com
Jisheng Wang, MD
About this study
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.
- Conditions
- Recurrent High-grade Glioma
- Being tested
- Ultra-low dose Bevacizumab, Temozolomide
- Keywords
- glioma, high-grade glioma
- Medical subject headings
- Glioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultra-low dose BevacizumabDrug
Also called BVZ
TemozolomideDrug
Also called TMZ
| Study group | Role | What they receive |
|---|---|---|
| patient group | Experimental | Not described Receives: Drug: Ultra-low dose Bevacizumab; Drug: Temozolomide |
What is being measured
The primary outcome is the main question the study is designed to answer.
6-month survival rate of recurrent glioblastoma multiforme patients under ultra-low dose Bevacizumab plus Temozolomide treatment
Measured: 6 months
12-month survival rate of recurrent WHO-III glioma patients under ultra-low dose Bevacizumab plus Temozolomide treatment
Measured: 12 months
Secondary outcomes (6)
Overall survival of recurrent glioblastoma multiforme patients under ultra-low dose Bevacizumab plus Temozolomide treatment
Measured: 6 months or later, up to 12 months
Overall survival of recurrent WHO-III glioma patients under ultra-low dose Bevacizumab plus Temozolomide treatment
Measured: 12 months or later, up to 24 months
Progression free survival of recurrent glioblastoma multiforme patients under ultra-low dose Bevacizumab plus Temozolomide treatment
Measured: 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
Measured: 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)
Measured: 6 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)
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2015 (estimated)
- Study startMay 2015
- Primary completionMay 2018 (estimated)
- Study completionMay 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent High-grade GliomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hebei Yanda Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Beijing Tiantan Hospital
- Responsible party
- Sponsor
- Investigators
- Jisheng Wang, MD, Principal investigator, Beijing Tiantan HospitalNan Ji, MD, Principal investigator, Beijing Tiantan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02416999
- Sponsor's protocol ID
- YDCR-2015-001
- Status last verified
- Feb 2016
- First submitted
- 1 Apr 2015
- Last updated
- 18 Feb 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultra-low Dose Bevacizumab Plus Temozolomide for Recurrent High-grade Gliomas
- ClinicalTrials.gov ID
- NCT02416999
- Acronym / sponsor ID
- YDCR-2015-001
- Conditions
- Recurrent High-grade Glioma
- Keywords
- glioma, high-grade glioma
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Hebei Yanda HospitalUniversity, hospital or other
- Collaborators
- Beijing Tiantan Hospital
- Study start
- May 2015
- Primary completion
- May 2018 (estimated)
- Study completion
- May 2018 (estimated)
- First posted
- 15 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patient group | Experimental | Drug: Ultra-low dose Bevacizumab, Drug: Temozolomide |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ultra-low dose BevacizumabAlso: BVZ | Drug | patient group |
| TemozolomideAlso: TMZ | Drug | patient group |
Primary outcome
6-month survival rate of recurrent glioblastoma multiforme patients under ultra-low dose Bevacizumab plus Temozolomide treatment
Time frame: 6 months
12-month survival rate of recurrent WHO-III glioma patients under ultra-low dose Bevacizumab plus Temozolomide treatment
Time frame: 12 months
6 secondary outcomes
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
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
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
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
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
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jisheng Wang, MD principal investigator
Beijing Tiantan Hospital
Nan Ji, MD principal investigator
Beijing Tiantan Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultra-low dose Bevacizumab and Temozolomide in people with Recurrent High-grade Glioma, run by Hebei Yanda Hospital at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nan Ji, MD (+86 13910713896, neurochina@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
6-month survival rate of recurrent glioblastoma multiforme patients under ultra-low dose Bevacizumab plus Temozolomide treatment (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2016.