Iodine-125 Brachytherapy Together With Chemotherapy in Patients With Newly Diagnosed Glioblastoma

Study Overview
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Brief Summary
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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
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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).

Official Title
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Iodine-125 Brachytherapy Together With Chemotherapy Compared With Surgical Resection Followed by Concomitant Radiochemotherapy in Patients With Newly Diagnosed Glioblastoma，a Randomized, Open-label, Multi-center Clinical Trial

Conditions
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Glioblastoma

Intervention / Treatment
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* Other: Iodine-125+Chemotherapy
* Other: Surgical resection+Radiochemotherapy


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Iodine-125+Chemotherapy<br>Iodine-125; Temozolomide | Other: Iodine-125+Chemotherapy<br>* 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.<br>* Other names: Iodine-125+Temozolomide;|
| Active Comparator: Surgical resection+Radiochemotherapy<br>Surgical resection; Radiotherapy; Temozolomide: | Other: Surgical resection+Radiochemotherapy<br>* 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.<br>* Other names: Surgical resection+Radiotherapy+Temozolomide;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free survival (PFS) | PFS is defined as the time from randomization to progression or death from any causes. Progression is defined as the RANO Criteria indicated. | 2.5 years after randomization | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival (OS) | OS is defined as the time from randomization to death from any causes. | 2.5 years after randomization | 
| Survival rates at 6 months and 1 year | The survival rates were measured at 6 months and 1 year | at 6 months and 1 year after operation respectively | 
| EORTC QLQ-C30 | 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. | 2.5 year after randomization | 
| ECOG Performance Status | 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. | 2.5 year after randomization | 
| Complications | Complications 1 week after operation were assessed. The complications after operation include headache, nausea, vomit, myodynamia, seizer, and so on. | within 1 week after operation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Glioblastoma, Iodine-125, Surgical resection, Radiochemotherapy, Chemotherapy, Radiation