Back to resultsA Study to Evaluate the Safety and Effectiveness of PCV Chemotherapy in Patients With Recurrent High-grade Glioma With IDH1/2 Mutation
Primary Purpose
Recurrent High-grade Glioma
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Lomustine/Vincristine/Procarbazine
Sponsored by
About this trial
This is an interventional treatment trial for Recurrent High-grade Glioma
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Sites / Locations
- Beijing Tiantan Hospital
- Hebei Yanda Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
case group
Arm Description
Outcomes
Primary Outcome Measures
progression free survival
Secondary Outcome Measures
6-month progression-free survival rate
12-month progression-free survival rate
6-month survival rate
12-month survival rate
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
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
Full Information
NCT ID
NCT02333513
First Posted
January 6, 2015
Last Updated
April 8, 2015
Sponsor
Hebei Yanda Hospital
Collaborators
Beijing Tiantan Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02333513
Brief Title
A Study to Evaluate the Safety and Effectiveness of PCV Chemotherapy in Patients With Recurrent High-grade Glioma With IDH1/2 Mutation
Official Title
A Study to Evaluate the Safety and Effectiveness of PCV Chemotherapy in Patients With Recurrent High-grade Glioma With IDH1/2 Mutation
Study Type
Interventional
2. Study Status
Record Verification Date
April 2015
Overall Recruitment Status
Unknown status
Study Start Date
February 2015 (undefined)
Primary Completion Date
December 2017 (Anticipated)
Study Completion Date
December 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hebei Yanda Hospital
Collaborators
Beijing Tiantan Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Recurrent High-grade Glioma
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
case group
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Lomustine/Vincristine/Procarbazine
Primary Outcome Measure Information:
Title
progression free survival
Time Frame
12 months or later
Secondary Outcome Measure Information:
Title
6-month progression-free survival rate
Time Frame
6 month
Title
12-month progression-free survival rate
Time Frame
12 month
Title
6-month survival rate
Time Frame
6 month
Title
12-month survival rate
Time Frame
12 month
Title
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
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nan Ji, Medical Doctor
Phone
+86 15210503095
Email
neurochina@sohu.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nan Ji, Medical Doctor
Organizational Affiliation
Beijing Tiantan Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beijing Tiantan Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100050
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nan Ji, Medical Doctor
Phone
+86 15210503095
Email
neurochina@sohu.com
Facility Name
Hebei Yanda Hospital
City
Sanhe
State/Province
Hebei
ZIP/Postal Code
065200
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nan Ji, Medical Doctor
Phone
+86 15210503095
Email
neurochina@sohu.com
12. IPD Sharing Statement
Learn more about this trial
A Study to Evaluate the Safety and Effectiveness of PCV Chemotherapy in Patients With Recurrent High-grade Glioma With IDH1/2 Mutation
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