Back to resultsIodine-125 Brachytherapy Together With Chemotherapy in Patients With Newly Diagnosed Glioblastoma (IBCNG)
Primary Purpose
Glioblastoma
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Iodine-125+Chemotherapy
Surgical resection+Radiochemotherapy
Sponsored by
About this trial
This is an interventional treatment trial for Glioblastoma focused on measuring Glioblastoma, Iodine-125, Surgical resection, Radiochemotherapy, Chemotherapy, Radiation
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Iodine-125+Chemotherapy
Surgical resection+Radiochemotherapy
Arm Description
Iodine-125; Temozolomide
Surgical resection; Radiotherapy; Temozolomide:
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Overall Survival (OS)
OS is defined as the time from randomization to death from any causes.
Survival rates at 6 months and 1 year
The survival rates were measured at 6 months and 1 year
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.
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.
Complications
Complications 1 week after operation were assessed. The complications after operation include headache, nausea, vomit, myodynamia, seizer, and so on.
Full Information
NCT ID
NCT04856852
First Posted
April 20, 2021
Last Updated
June 28, 2021
Sponsor
The Affiliated Hospital of Qingdao University
1. Study Identification
Unique Protocol Identification Number
NCT04856852
Brief Title
Iodine-125 Brachytherapy Together With Chemotherapy in Patients With Newly Diagnosed Glioblastoma
Acronym
IBCNG
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2021
Overall Recruitment Status
Unknown status
Study Start Date
June 28, 2021 (Anticipated)
Primary Completion Date
August 1, 2022 (Anticipated)
Study Completion Date
August 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Affiliated Hospital of Qingdao University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glioblastoma
Keywords
Glioblastoma, Iodine-125, Surgical resection, Radiochemotherapy, Chemotherapy, Radiation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
84 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Iodine-125+Chemotherapy
Arm Type
Experimental
Arm Description
Iodine-125; Temozolomide
Arm Title
Surgical resection+Radiochemotherapy
Arm Type
Active Comparator
Arm Description
Surgical resection; Radiotherapy; Temozolomide:
Intervention Type
Other
Intervention Name(s)
Iodine-125+Chemotherapy
Other Intervention Name(s)
Iodine-125+Temozolomide
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Surgical resection+Radiochemotherapy
Other Intervention Name(s)
Surgical resection+Radiotherapy+Temozolomide
Intervention Description
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.
Primary Outcome Measure Information:
Title
Progression-free survival (PFS)
Description
PFS is defined as the time from randomization to progression or death from any causes. Progression is defined as the RANO Criteria indicated.
Time Frame
2.5 years after randomization
Secondary Outcome Measure Information:
Title
Overall Survival (OS)
Description
OS is defined as the time from randomization to death from any causes.
Time Frame
2.5 years after randomization
Title
Survival rates at 6 months and 1 year
Description
The survival rates were measured at 6 months and 1 year
Time Frame
at 6 months and 1 year after operation respectively
Title
EORTC QLQ-C30
Description
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.
Time Frame
2.5 year after randomization
Title
ECOG Performance Status
Description
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.
Time Frame
2.5 year after randomization
Title
Complications
Description
Complications 1 week after operation were assessed. The complications after operation include headache, nausea, vomit, myodynamia, seizer, and so on.
Time Frame
within 1 week after operation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xiaokun Hu, PhD
Phone
+8618661801166
Email
huxiaokun770@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xiaokun Hu, MD
Organizational Affiliation
The Affiliated Hospital of Qingdao University
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Iodine-125 Brachytherapy Together With Chemotherapy in Patients With Newly Diagnosed Glioblastoma
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