GlioblastomaIBCNGNCT04856852
Iodine-125 Brachytherapy Together With Chemotherapy in Patients With Newly Diagnosed Glioblastoma
A study testing Iodine-125+Chemotherapy and Surgical resection+Radiochemotherapy in people with Glioblastoma, run by The Affiliated Hospital of Qingdao University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Glioblastoma
- What is being tested?
- Iodine-125+Chemotherapy and Surgical resection+Radiochemotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- No sites listed yet
- Study dates
- 28 Jun 2021to 31 Aug 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
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- 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.
Trial locations and contacts
No sites are listed yet.
About this study
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
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.
Read the 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).
- Conditions
- Glioblastoma
- Being tested
- Iodine-125+Chemotherapy, Surgical resection+Radiochemotherapy
- Keywords
- Glioblastoma, Iodine-125, Surgical resection, Radiochemotherapy, Chemotherapy, Radiation
- Medical subject headings
- Glioblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Iodine-125+ChemotherapyOther
Also called Iodine-125+Temozolomide
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+RadiochemotherapyOther
Also called Surgical resection+Radiotherapy+Temozolomide
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.
| Study group | Role | What they receive |
|---|---|---|
| Iodine-125+Chemotherapy | Experimental | Iodine-125; Temozolomide Receives: Other: Iodine-125+Chemotherapy |
| Surgical resection+Radiochemotherapy | Active comparator | Surgical resection; Radiotherapy; Temozolomide: Receives: Other: Surgical resection+Radiochemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2.5 years after randomization
Secondary outcomes (5)
Overall Survival (OS)
OS is defined as the time from randomization to death from any causes.
Measured: 2.5 years after randomization
Survival rates at 6 months and 1 year
The survival rates were measured at 6 months and 1 year
Measured: 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.
Measured: 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.
Measured: 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.
Measured: within 1 week after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2021
- Study start28 Jun 2021 (estimated)
- Primary completion1 Aug 2022 (estimated)
- Study completion31 Aug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GlioblastomaStudies of the same condition, open and under way.
- More trials run by The Affiliated Hospital of Qingdao UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Affiliated Hospital of Qingdao University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Xiaokun Hu, MD, Principal investigator, The Affiliated Hospital of Qingdao University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04856852
- Sponsor's protocol ID
- IC-SRC-20201119
- Other IDs
- 2019YFE0120100
- Acronym
- IBCNG
- Status last verified
- Jun 2021
- First submitted
- 20 Apr 2021
- Last updated
- 29 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04856852
- Acronym / sponsor ID
- IBCNG / IC-SRC-20201119
- Conditions
- Glioblastoma
- Keywords
- Glioblastoma, Iodine-125, Surgical resection, Radiochemotherapy, Chemotherapy, Radiation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- The Affiliated Hospital of Qingdao UniversityUniversity, hospital or other
- Study start
- 28 Jun 2021 (estimated)
- Primary completion
- 1 Aug 2022 (estimated)
- Study completion
- 31 Aug 2023 (estimated)
- First posted
- 23 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Iodine-125+Chemotherapy | Experimental | Other: Iodine-125+ChemotherapyIodine-125; Temozolomide |
| Surgical resection+Radiochemotherapy | Active comparator | Other: Surgical resection+RadiochemotherapySurgical resection; Radiotherapy; Temozolomide: |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Iodine-125+ChemotherapyAlso: Iodine-125+TemozolomideIodine-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. | Other | Iodine-125+Chemotherapy |
| Surgical resection+RadiochemotherapyAlso: Surgical resection+Radiotherapy+TemozolomideSurgical 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 | Surgical resection+Radiochemotherapy |
Primary outcome
Progression-free survival (PFS)
Time frame: 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.
5 secondary outcomes
Overall Survival (OS)
Time frame: 2.5 years after randomization
Survival rates at 6 months and 1 year
Time frame: at 6 months and 1 year after operation respectively
EORTC QLQ-C30
Time frame: 2.5 year after randomization
ECOG Performance Status
Time frame: 2.5 year after randomization
Complications
Time frame: within 1 week after operation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xiaokun Hu, MD principal investigator
The Affiliated Hospital of Qingdao University
Questions about this trial
What is this clinical trial studying?
A study testing Iodine-125+Chemotherapy and Surgical resection+Radiochemotherapy in people with Glioblastoma, run by The Affiliated Hospital of Qingdao University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xiaokun Hu, PhD (+8618661801166, huxiaokun770@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival (PFS) (time frame: 2.5 years after randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2021.