Recurrent High-grade Glioma
Conditions
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.
Interventions
DRUGLomustine/Vincristine/Procarbazine
Sponsors
Beijing Tiantan Hospital
Hebei Yanda Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| progression free survival | 12 months or later |
Secondary
| Measure | Time frame |
|---|---|
| 12-month progression-free survival rate | 12 month |
| 6-month survival rate | 6 month |
| 6-month progression-free survival rate | 6 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 |
| 12-month survival rate | 12 month |
Countries
China
Contacts
Primary ContactNan Ji, Medical Doctor
Outcome results
None listed