Clinical trial NCT02333513: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Recurrent High-grade Glioma
Lead sponsor: Hebei Yanda Hospital
Sponsor class: OTHER
Collaborators: name: Beijing Tiantan Hospital
First posted: 2015-01-07
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: progression free survival
timeFrame: 12 months or later
Secondary outcomes:
measure: 6-month progression-free survival rate
timeFrame: 6 month
measure: 12-month progression-free survival rate
timeFrame: 12 month
measure: 6-month survival rate
timeFrame: 6 month
measure: 12-month survival rate
timeFrame: 12 month
measure: 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
timeFrame: 6 month
measure: 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
timeFrame: 12 month
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Tiantan Hospital
state: Beijing
city: Sanhe
country: China
facility: Hebei Yanda Hospital
state: Hebei
Study officials:
affiliation: Beijing Tiantan Hospital
name: Nan Ji, Medical Doctor
role: PRINCIPAL_INVESTIGATOR
References: