Iodine-125 Brachytherapy Together With Chemotherapy in Patients With Newly Diagnosed Glioblastoma
NCT ID: NCT04856852
Last Updated: 2021-06-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
84 participants
INTERVENTIONAL
2021-06-28
2023-08-31
Brief Summary
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Detailed Description
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The primary efficacy outcome was evaluated with progression-free survival (PFS).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Iodine-125+Chemotherapy
Iodine-125; Temozolomide
Iodine-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.
Surgical resection+Radiochemotherapy
Surgical resection; Radiotherapy; Temozolomide:
Surgical 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.
Interventions
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Iodine-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.
Surgical 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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
75 Years
ALL
No
Sponsors
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The Affiliated Hospital of Qingdao University
OTHER
Responsible Party
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Principal Investigators
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Xiaokun Hu, MD
Role: PRINCIPAL_INVESTIGATOR
The Affiliated Hospital of Qingdao University
Central Contacts
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Other Identifiers
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2019YFE0120100
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
IC-SRC-20201119
Identifier Type: -
Identifier Source: org_study_id
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