Glioma of BrainPhase 2/3NCT03534050
Neuropsychological and Oncological Outcomes in Grade 2 or 3 Glioma Patients Undergoing Postoperative Modern Radiotherapy
A Phase 2/3 study testing postoperative adjuvant RT in people with Glioma of Brain, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial summary
Background: Infiltrative low grade gliomas (LGGs) are the most common primary central nervous system malignancies excluding the highest grade glioma, glioblastoma multiforme. Craniotomy with maximal safe tumor resection is endeavored to achieve longer survivals in LGG patients. Read more about this study
- Who is it for?
- Ages 20 to 84 years
- Conditions the study is for
- Glioma of Brain
- What is being tested?
- postoperative adjuvant RT
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Aug 2016to 31 Jul 2026
- Phase
- Phase 2/3
- 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 20 to 84 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients with infiltrative low-grade gliomas who have received craniotomy plus tumor removal or at least biopsy with pathologic conformation; brain radiation therapy is recommended owning to some high-risk features including subtotal resection (STR) or age at craniotomy older than 40 years old
- Good performance status no worse than Eastern Cooperative Group (ECOG) of 2 or a general status of Karnofsky Score (KPS) at least 70 %
Who cannot join
- A pathological diagnosis confirmed to be WHO grade IV glioma (i.e., glioblastoma multiforme) or grade I disease (i.e., pilocystic astrocytoma)
- Radiographic evidence of gliomatosis cerebri
- Prior cranial irradiation for any reasons
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Chang Gung Memorial Hospital
Taoyuan, 333
Shinn-Yn Lin, M.D., +886-33281200 ext. 7172, rt3126@gmail.com
About this study
Official title: Neuropsychological and Oncological Outcomes in Grade 2 or 3 Glioma Patients Undergoing Postoperative Modern Radiotherapy - A Prospective Follow-up Study
Background: Infiltrative low grade gliomas (LGGs) are the most common primary central nervous system malignancies excluding the highest grade glioma, glioblastoma multiforme. Craniotomy with maximal safe tumor resection is endeavored to achieve longer survivals in LGG patients. Unfortunately, due to the infiltrative nature of gliomas and the frequent tumor location in eloquent areas, gross total resection is usually not applicable. According to National Comprehensive Cancer Network 2015 guidelines, postoperative adjuvant radiation therapy (RT) is recommended for most adult patients with low-grade infiltrative LGGs in order to enhance local control and prolong progression-free survival (PFS), except those who are no older than 40 years of age and in whom maximal safe resection is not feasible. However, brain irradiation-related neurocognitive function (NCF) sequelae are potentially and indeed a concern which should not be ignored. In terms of the time course of cranial irradiation-induced NCF decline, it might vary considerably according to the specific domains which are selected to be measured. Early neurocognitive decline principally involve impairments of episodic memory, which has been significantly associated with functions of the hippocampus. This study thus aims to investigate the impact of partial brain irradiation with using contemporary radiotherapeutic techniques on neurocognitive performances, intracranial local control, and progression-free survival in patients with intracranial high-risk grade 2 or 3 gliomas.
Methods: Patients with intracranial high-risk low-grade or grade 3 gliomas will be enrolled to this study once postoperative adjuvant RT is recommended. All eligible and recruited patients should receive baseline functional brain MRI examination and baseline neurobehavioral assessment. Subsequently, partial cranial irradiation will be initiated within one month approximately after enrollment. Brain RT dose will be 5000 - 6000 cGy in 25 - 30 fraction during 5 - 7 weeks. Accordingly, a battery of neuropsychological measures, which includes 7 standardized neuropsychological tests (e.g., executive functions, verbal \& non-verbal memory, working memory, and psychomotor speed), is used to evaluate neurobehavioral functions for our registered patients. The primary outcome measure is delayed recall, as determined by the change/decline in verbal memory or non-verbal memory from the baseline assessment to 4 months after the start of postoperative adjuvant RT.
- Conditions
- Glioma of Brain
- Being tested
- postoperative adjuvant RT
- Keywords
- Glioma, Low-Grade Glioma (LGG), Neurobehavioral Assessments, Neurocognitive Functions (NCF), Radiation Therapy (RT), Hippocampus, Progression-Free Survival (PFS)
- Medical subject headings
- Glioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
postoperative adjuvant RTRadiation
| Study group | Role | What they receive |
|---|---|---|
| postoperative adjuvant RT | Experimental | In this prospective observational study, all potentially eligible patients are clinically indicated for receiving postoperative adjuvant RT. Namely, partial cranial irradiation will be initiated within one month approximately after enrollment. Prescription dose will be 5000 - 6000 cGy in 25 - 30 fraction during 5 - 7 weeks. Receives: Radiation: postoperative adjuvant RT |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary endpoint is delayed recall, as determined by the change/decline in verbal memory (WMS III- Word List score) from the baseline assessment to 4 months after the start of postoperative adjuvant RT.
Neurocognitive assessment: including memory, executive functions, and psychomotor speed. This neurocognitive outcome was delayed recall, as determined by the change/decline in verbal memory [Wechsler Memory Scale - 3rd edition (WMS III) - Word List score] from the baseline assessment to 4 months after the start of the course of postoperative adjuvant RT.
Measured: 4 months after the start of postoperative adjuvant RT
The primary endpoint is delayed recall, as determined by the change/decline in non-verbal memory (WMS III- Visual Reproduction score) from the baseline assessment to 4 months after the start of postoperative adjuvant RT.
Neurocognitive assessment: including memory, executive functions, and psychomotor speed. This neurocognitive outcome was delayed recall, as determined by the change/decline in non-verbal memory (WMS III- Visual Reproduction score) from the baseline assessment to 4 months after the start of the course of postoperative adjuvant RT.
Measured: 4 months after the start of postoperative adjuvant RT
Secondary outcomes (3)
Overall survival time, indicated by the time from the date of recruitment to the date of expiring.
Measured: up to 24 months
The time from the date of recruitment to that of intracranial progression/failure noted on brain MRI or CT.
Measured: up to 24 months
The delayed recall will follow up until 24 months after the start of postoperative adjuvant RT.
The follow-up of neurocognitive assessment will be administered at 8 months, 12 months, 18 months and up to 24 months after the start of postoperative adjuvant RT.
Measured: up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2018
- Study start1 Aug 2016
- Primary completion31 Jul 2026 (estimated)
- Study completion31 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Glioma of BrainStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe 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 2/3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03534050
- Sponsor's protocol ID
- 104-9201B
- Status last verified
- Mar 2023
- First submitted
- 2 Apr 2018
- Last updated
- 1 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lin SY, Chuang CC, Huang YC, Pai PC, Lee CC, Wei KC, Tseng CK, Yang CC. Neuropsychological performances in patients with infiltrative non-GBM gliomas after postoperative adjuvant photon or proton radiotherapy: A prospective and preliminary investigation. Appl Neuropsychol Adult. 2024 Jul-Aug;31(4):606-615. doi: 10.1080/23279095.2022.2048830. Epub 2022 Mar 27.
PubMed 35343323
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuropsychological and Oncological Outcomes in Grade 2 or 3 Glioma Patients Undergoing Postoperative Modern Radiotherapy - A Prospective Follow-up Study
- ClinicalTrials.gov ID
- NCT03534050
- Acronym / sponsor ID
- 104-9201B
- Conditions
- Glioma of Brain
- Keywords
- Glioma, Low-Grade Glioma (LGG), Neurobehavioral Assessments, Neurocognitive Functions (NCF), Radiation Therapy (RT), Hippocampus, Progression-Free Survival (PFS)
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 1 Aug 2016 (actual)
- Primary completion
- 31 Jul 2026 (estimated)
- Study completion
- 31 Jul 2026 (estimated)
- First posted
- 23 May 2018 (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.
Background: Infiltrative low grade gliomas (LGGs) are the most common primary central nervous system malignancies excluding the highest grade glioma, glioblastoma multiforme. Craniotomy with maximal safe tumor resection is endeavored to achieve longer survivals in LGG patients. Unfortunately, due to the infiltrative nature of gliomas and the frequent tumor location in eloquent areas, gross total resection is usually not applicable. According to National Comprehensive Cancer Network 2015 guidelines, postoperative adjuvant radiation therapy (RT) is recommended for most adult patients with low-grade infiltrative LGGs in order to enhance local control and prolong progression-free survival (PFS), except those who are no older than 40 years of age and in whom maximal safe resection is not feasible. However, brain irradiation-related neurocognitive function (NCF) sequelae are potentially and indeed a concern which should not be ignored. In terms of the time course of cranial irradiation-induced NCF decline, it might vary considerably according to the specific domains which are selected to be measured. Early neurocognitive decline principally involve impairments of episodic memory, which has been significantly associated with functions of the hippocampus. This study thus aims to investigate the impact of partial brain irradiation with using contemporary radiotherapeutic techniques on neurocognitive performances, intracranial local control, and progression-free survival in patients with intracranial high-risk grade 2 or 3 gliomas.
Methods: Patients with intracranial high-risk low-grade or grade 3 gliomas will be enrolled to this study once postoperative adjuvant RT is recommended. All eligible and recruited patients should receive baseline functional brain MRI examination and baseline neurobehavioral assessment. Subsequently, partial cranial irradiation will be initiated within one month approximately after enrollment. Brain RT dose will be 5000 - 6000 cGy in 25 - 30 fraction during 5 - 7 weeks. Accordingly, a battery of neuropsychological measures, which includes 7 standardized neuropsychological tests (e.g., executive functions, verbal \& non-verbal memory, working memory, and psychomotor speed), is used to evaluate neurobehavioral functions for our registered patients. The primary outcome measure is delayed recall, as determined by the change/decline in verbal memory or non-verbal memory from the baseline assessment to 4 months after the start of postoperative adjuvant RT.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| postoperative adjuvant RT | Experimental | Radiation: postoperative adjuvant RTIn this prospective observational study, all potentially eligible patients are clinically indicated for receiving postoperative adjuvant RT. Namely, partial cranial irradiation will be initiated within one month approximately after enrollment. Prescription dose will be 5000 - 6000 cGy in 25 - 30 fraction during 5 - 7 weeks. |
Who may qualify
- Ages
- 20 to 84 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- All patients with infiltrative low-grade gliomas who have received craniotomy plus tumor removal or at least biopsy with pathologic conformation; brain radiation therapy is recommended owning to some high-risk features including subtotal resection (STR) or age at craniotomy older than 40 years old
- Good performance status no worse than Eastern Cooperative Group (ECOG) of 2 or a general status of Karnofsky Score (KPS) at least 70 %
Key exclusion criteria (3 listed)
- A pathological diagnosis confirmed to be WHO grade IV glioma (i.e., glioblastoma multiforme) or grade I disease (i.e., pilocystic astrocytoma)
- Radiographic evidence of gliomatosis cerebri
- Prior cranial irradiation for any reasons
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 |
|---|---|---|
| postoperative adjuvant RT | Radiation | postoperative adjuvant RT |
Primary outcome
The primary endpoint is delayed recall, as determined by the change/decline in verbal memory (WMS III- Word List score) from the baseline assessment to 4 months after the start of postoperative adjuvant RT.
Time frame: 4 months after the start of postoperative adjuvant RT
Neurocognitive assessment: including memory, executive functions, and psychomotor speed. This neurocognitive outcome was delayed recall, as determined by the change/decline in verbal memory [Wechsler Memory Scale - 3rd edition (WMS III) - Word List score] from the baseline assessment to 4 months after the start of the course of postoperative adjuvant RT.
The primary endpoint is delayed recall, as determined by the change/decline in non-verbal memory (WMS III- Visual Reproduction score) from the baseline assessment to 4 months after the start of postoperative adjuvant RT.
Time frame: 4 months after the start of postoperative adjuvant RT
Neurocognitive assessment: including memory, executive functions, and psychomotor speed. This neurocognitive outcome was delayed recall, as determined by the change/decline in non-verbal memory (WMS III- Visual Reproduction score) from the baseline assessment to 4 months after the start of the course of postoperative adjuvant RT.
3 secondary outcomes
Overall survival time, indicated by the time from the date of recruitment to the date of expiring.
Time frame: up to 24 months
The time from the date of recruitment to that of intracranial progression/failure noted on brain MRI or CT.
Time frame: up to 24 months
The delayed recall will follow up until 24 months after the start of postoperative adjuvant RT.
Time frame: up to 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2023.
- Derived from this study: PubMed 35343323Lin SY, Chuang CC, Huang YC, Pai PC, Lee CC, Wei KC, Tseng CK, Yang CC. Neuropsychological performances in patients with infiltrative non-GBM gliomas after postoperative adjuvant photon or proton radiotherapy: A prospective and preliminary investigation. Appl Neuropsychol Adult. 2024 Jul-Aug;31(4):606-615. doi: 10.1080/23279095.2022.2048830. Epub 2022 Mar 27.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing postoperative adjuvant RT in people with Glioma of Brain, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
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 2 inclusion and 3 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 1 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Shinn-Yn Lin, M.D. (+886-33281200 ext. 7172, rt3126@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary endpoint is delayed recall, as determined by the change/decline in verbal memory (WMS III- Word List score) from the baseline assessment to 4 months after the start of postoperative adjuvant RT. (time frame: 4 months after the start of postoperative adjuvant RT). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03534050, which also lists 1 linked publication.
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 1 May 2023.