Glioblastoma
Conditions
Keywords
Glioblastoma, Iodine-125, Surgical resection, Radiochemotherapy, Chemotherapy, Radiation
Brief summary
The purpose of this study is to evaluate the efficacy and safety of Iodine-125 brachytherapy together with chemotherapy compared with surgical resection followed by concomitant radiochemotherapy in patients with newly diagnosed glioblastoma.
Detailed description
This is a prospective, multicentric open-label trial to evaluate the efficacy and safety of Iodine-125 brachytherapy together with chemotherapy compared with surgical resection followed by concomitant radiochemotherapy in patients with newly diagnosed glioblastoma. The primary efficacy outcome was evaluated with progression-free survival (PFS).
Interventions
OTHERIodine-125+Chemotherapy
Iodine-125: Iodine-125 if necessary, 0.6-0.8mCi, PD:120-150Gy Temozolomide: 75 mg per square meter of body-surface area per day, 7 days per week,42 days.
OTHERSurgical resection+Radiochemotherapy
Surgical resection: Maximal surgical resection, including gross total resection, subtotal resection, and partial resection. Radiation: total 60 Gy, 2 Gy per daily fraction (Monday to Friday) for 6 weeks. Temozolomide: 75 mg per square meter of body-surface area per day, 7 days per week,42 days.
Sponsors
The Affiliated Hospital of Qingdao University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* 1\. Diagnosis of glioblastoma confirmed by histology * 2\. Age: 18-75 years old * 3\. Single lesion located in one hemisphere with a diameter between 2 and 6 centimeters * 4\. No prior anticancer therapy for glioblastoma besides biopsy. * 5\. ECOG PS：0-2 point
Exclusion criteria
* 1\. Infra-tentorial tumor or tumor involves the ependymal surface. * 2\. Nonmeasurable disease. * 3\. Evidence of uncontrolled intracranial pressure. * 4\. Severe heart, brain, and lung diseases. * 5.Severe hepatic or renal dysfunction. * 6\. Uncontrolled, active infection. * 7\. Severe clotting dysfunction. * 8\. Pregnant. * 9\. Uncontrolled hypertension. * 10\. Participated in any other clinical treatment trial within 4 weeks before randomization. * 11\. Severe vascular diseases within 6 months before randomization. * 12\. Participants who received major surgical treatment within 4 weeks or were expected to be treated during the trial.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression-free survival (PFS) | 2.5 years after randomization | PFS is defined as the time from randomization to progression or death from any causes. Progression is defined as the RANO Criteria indicated. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival (OS) | 2.5 years after randomization | OS is defined as the time from randomization to death from any causes. |
| Survival rates at 6 months and 1 year | at 6 months and 1 year after operation respectively | The survival rates were measured at 6 months and 1 year |
| EORTC QLQ-C30 | 2.5 year after randomization | The Quality of life is measured with EORTC QLQ-C30 (The European Organization for Research and Treatment of Cancer Core Quality of Life questionnaire). The EORTC QLQ-C30 is designed to measure cancer patients' physical, psychological and social functions. The questionnaire is composed of multi-item scales and single items. |
| ECOG Performance Status | 2.5 year after randomization | ECOG PS (Eastern Cooperative Oncology Group, performance status) is to assess how a patient's disease is progressing, and how the disease affects the daily living abilities of the patient, and determine appropriate treatment and prognosis. The scale is from 0 to 5. Higher scores mean a worse outcome. |
| Complications | within 1 week after operation | Complications 1 week after operation were assessed. The complications after operation include headache, nausea, vomit, myodynamia, seizer, and so on. |
Contacts
Primary ContactXiaokun Hu, PhD
Outcome results
None listed