Status:
UNKNOWN
Iodine-125 Brachytherapy Together With Chemotherapy in Patients With Newly Diagnosed Glioblastoma
Lead Sponsor:
The Affiliated Hospital of Qingdao University
Conditions:
Glioblastoma
Eligibility:
All Genders
18-75 years
Phase:
NA
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 pa...
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...
Eligibility Criteria
Inclusion
- 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
- 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.
- 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.
Key Trial Info
Start Date :
June 28 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 31 2023
Estimated Enrollment :
84 Patients enrolled
Trial Details
Trial ID
NCT04856852
Start Date
June 28 2021
End Date
August 31 2023
Last Update
June 29 2021
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