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

April 8, 2015 updated by: Hebei Yanda Hospital
This trial is aimed at evaluating the safety and effectiveness of PCV chemotherapy in patients with recurrent high-grade glioma with IDH1/2 mutation.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100050
        • Beijing Tiantan Hospital
        • Contact:
    • Hebei
      • Sanhe, Hebei, China, 065200
        • Hebei Yanda Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: case group
Drug: Lomustine/Vincristine/Procarbazine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
progression free survival
Time Frame: 12 months or later
12 months or later

Secondary Outcome Measures

Outcome Measure
Time Frame
6-month progression-free survival rate
Time Frame: 6 month
6 month
12-month progression-free survival rate
Time Frame: 12 month
12 month
6-month survival rate
Time Frame: 6 month
6 month
12-month survival rate
Time Frame: 12 month
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
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
12 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hebei Yanda Hospital

Collaborators

Beijing Tiantan Hospital

Investigators

  • Principal Investigator: Nan Ji, Medical Doctor, Beijing Tiantan Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2015

Primary Completion (Anticipated)

December 1, 2017

Study Completion (Anticipated)

December 1, 2017

Study Registration Dates

First Submitted

January 6, 2015

First Submitted That Met QC Criteria

January 6, 2015

First Posted (Estimate)

January 7, 2015

Study Record Updates

Last Update Posted (Estimate)

April 9, 2015

Last Update Submitted That Met QC Criteria

April 8, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • YDCR-2014-006
  • ChiCTR-OOC-15005759 (Registry Identifier: Chinese Clinical Trial Registry)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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