A Study to Evaluate the Safety and Effectiveness of PCV Chemotherapy in Patients With Recurrent High-grade Glioma With IDH1/2 Mutation
2 other identifiers
interventional
100
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Feb 2015
Typical duration for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 6, 2015
CompletedFirst Posted
Study publicly available on registry
January 7, 2015
CompletedStudy Start
First participant enrolled
February 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2017
CompletedApril 9, 2015
April 1, 2015
2.8 years
January 6, 2015
April 8, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
progression free survival
12 months or later
Secondary Outcomes (6)
6-month progression-free survival rate
6 month
12-month progression-free survival rate
12 month
6-month survival rate
6 month
12-month survival rate
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
6 month
- +1 more secondary outcomes
Study Arms (1)
case group
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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.
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.
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Hebei Yanda Hospitallead
- Beijing Tiantan Hospitalcollaborator
Study Sites (2)
Beijing Tiantan Hospital
Beijing, Beijing Municipality, 100050, China
Hebei Yanda Hospital
Sanhe, Hebei, 065200, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Nan Ji, Medical Doctor
Beijing Tiantan Hospital
Central Study Contacts
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
January 6, 2015
First Posted
January 7, 2015
Study Start
February 1, 2015
Primary Completion
December 1, 2017
Study Completion
December 1, 2017
Last Updated
April 9, 2015
Record last verified: 2015-04