Recurrent High-grade GliomaNCT02333513
A Study to Evaluate the Safety and Effectiveness of PCV Chemotherapy in Patients With Recurrent High-grade Glioma With IDH1/2 Mutation
A study testing Lomustine/Vincristine/Procarbazine in people with Recurrent High-grade Glioma, run by Hebei Yanda Hospital at 2 sites in China.
Trial summary
This trial is aimed at evaluating the safety and effectiveness of PCV chemotherapy in patients with recurrent high-grade glioma with IDH1/2 mutation. 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?
- Lomustine/Vincristine/Procarbazine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 2 sitesChina
- Study dates
- Feb 2015to Dec 2017
- 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
- A diagnosis of high-grade glioma was established by pathological method,and the recurrency of the disease is ongoing.
- The report of the pathological diagnosis contained the status of IDH gene, and showed that IDH1/2 mutation existed.
- The age of the patient is between 18 years old and 70 years old.
- The condition of the patient permits the procedure of chemotherapy using PCV schema.
- 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.
- No molecular neuropathological report is available, or the report showed that IDH1/2 mutation did not exist.
- The age of the patient does not meet the requirement of this research.
- The condition of the patient does not permit the procedure of chemotherapy using PCV schema.
- There are other conditions that the clinicians believe that the PCV chemotherapy 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, Medical Doctor, +86 15210503095, neurochina@sohu.com
Hebei Yanda Hospital
Sanhe, Hebei, 065200
Nan Ji, Medical Doctor, +86 15210503095, neurochina@sohu.com
About this study
This trial is aimed at evaluating the safety and effectiveness of PCV chemotherapy in patients with recurrent high-grade glioma with IDH1/2 mutation.
Read the detailed description
This trial is aimed at evaluating the safety and effectiveness of PCV chemotherapy in patients with recurrent high-grade glioma with IDH1/2 mutation. And, this trial is approved by medical ethics committee of hebei yanda hospital. Also, the trial has got a registry code "ChiCTR-OOC-15005759" in China clinical trial registry. Researchers will conduct thsi trial from 2015/02 to 2017/12, and 100 recurrent high-grade glioma with IDH1/2 mutation patients will be recruited. Patients who are recruited will get PCV chemotherapy in ether Hebei Yanda Hospital or Beijing Tiantan hospital, and get follow-ups from clinicians.
- Conditions
- Recurrent High-grade Glioma
- Being tested
- Lomustine/Vincristine/Procarbazine
- Medical subject headings
- Glioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lomustine/Vincristine/ProcarbazineDrug
| Study group | Role | What they receive |
|---|---|---|
| case group | Experimental | Not described Receives: Drug: Lomustine/Vincristine/Procarbazine |
What is being measured
The primary outcome is the main question the study is designed to answer.
progression free survival
Measured: 12 months or later
Secondary outcomes (6)
6-month progression-free survival rate
Measured: 6 month
12-month progression-free survival rate
Measured: 12 month
6-month survival rate
Measured: 6 month
12-month survival rate
Measured: 12 month
6-month life quality as measured by European Organization for the Research and Treatment of Cancer Quality of Life questionnaires(EORTC QLQ-C30,EORTC QLQ-BN20) and other methods
Measured: 6 month
12-month life quality as measured by European Organization for the Research and Treatment of Cancer Quality of Life questionnaires(EORTC QLQ-C30,EORTC QLQ-BN20) and other methods
Measured: 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2015 (estimated)
- Study startFeb 2015
- Primary completionDec 2017 (estimated)
- Study completionDec 2017 (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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hebei Yanda Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Beijing Tiantan Hospital
- Responsible party
- Sponsor
- Investigators
- Nan Ji, Medical Doctor, Principal investigator, Beijing Tiantan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02333513
- Sponsor's protocol ID
- YDCR-2014-006
- Other IDs
- ChiCTR-OOC-15005759
- Status last verified
- Apr 2015
- First submitted
- 6 Jan 2015
- Last updated
- 9 Apr 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Evaluate the Safety and Effectiveness of PCV Chemotherapy in Patients With Recurrent High-grade Glioma With IDH1/2 Mutation
- ClinicalTrials.gov ID
- NCT02333513
- Acronym / sponsor ID
- YDCR-2014-006
- Conditions
- Recurrent High-grade Glioma
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Hebei Yanda HospitalUniversity, hospital or other
- Collaborators
- Beijing Tiantan Hospital
- Study start
- Feb 2015
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 7 Jan 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 trial is aimed at evaluating the safety and effectiveness of PCV chemotherapy in patients with recurrent high-grade glioma with IDH1/2 mutation.
Detailed description
This trial is aimed at evaluating the safety and effectiveness of PCV chemotherapy in patients with recurrent high-grade glioma with IDH1/2 mutation. And, this trial is approved by medical ethics committee of hebei yanda hospital. Also, the trial has got a registry code "ChiCTR-OOC-15005759" in China clinical trial registry. Researchers will conduct thsi trial from 2015/02 to 2017/12, and 100 recurrent high-grade glioma with IDH1/2 mutation patients will be recruited. Patients who are recruited will get PCV chemotherapy 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 |
|---|---|---|
| case group | Experimental | Drug: Lomustine/Vincristine/Procarbazine |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- A diagnosis of high-grade glioma was established by pathological method,and the recurrency of the disease is ongoing.
- The report of the pathological diagnosis contained the status of IDH gene, and showed that IDH1/2 mutation existed.
- The age of the patient is between 18 years old and 70 years old.
- The condition of the patient permits the procedure of chemotherapy using PCV schema.
- 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.
- No molecular neuropathological report is available, or the report showed that IDH1/2 mutation did not exist.
- The age of the patient does not meet the requirement of this research.
- The condition of the patient does not permit the procedure of chemotherapy using PCV schema.
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 |
|---|---|---|
| Lomustine/Vincristine/Procarbazine | Drug | case group |
Primary outcome
progression free survival
Time frame: 12 months or later
6 secondary outcomes
6-month progression-free survival rate
Time frame: 6 month
12-month progression-free survival rate
Time frame: 12 month
6-month survival rate
Time frame: 6 month
12-month survival rate
Time frame: 12 month
6-month life quality as measured by European Organization for the Research and Treatment of Cancer Quality of Life questionnaires(EORTC QLQ-C30,EORTC QLQ-BN20) and other methods
Time frame: 6 month
12-month life quality as measured by European Organization for the Research and Treatment of Cancer Quality of Life questionnaires(EORTC QLQ-C30,EORTC QLQ-BN20) and other methods
Time frame: 12 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2015.
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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.
Nan Ji, Medical Doctor 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 Lomustine/Vincristine/Procarbazine 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 9 Apr 2015. 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, Medical Doctor (+86 15210503095, neurochina@sohu.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
progression free survival (time frame: 12 months or later). 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 9 Apr 2015.