A Study to Evaluate the Safety and Effectiveness of PCV Chemotherapy in Patients With Recurrent High-grade Glioma With IDH1/2 Mutation

Not Applicable

• Conditions: Recurrent High-grade Glioma
• Interventions: Drug: Lomustine/Vincristine/Procarbazine

• Registration Number: NCT02333513
• Lead Sponsor: Hebei Yanda Hospital

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.

Study Timeline

• Study First Submitted: 2015-01-06
• Study First Submitted QC: 2015-01-06
• Study First Posted: 2015-01-07
• Study Start: 2015-02
• Status Verified: 2015-04
• Last Update Submitted: 2015-04-08
• Last Update Posted: 2015-04-09
• Primary Completion: 2017-12
• Study Completion: 2017-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
case group	Lomustine/Vincristine/Procarbazine	-

Primary Outcome Measures

Name	Time	Method
progression free survival	12 months or later

Secondary Outcome Measures

Name	Time	Method
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
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	12 month

Trial Locations

Locations (2)

Hebei Yanda Hospital; 🇨🇳 Sanhe, Hebei, China

Beijing Tiantan Hospital; 🇨🇳 Beijing, Beijing, China