Metastatic Malignant Neoplasm to BrainNCT02393131
Neurocognitive Outcome of Conformal WBRT w/wo Hippocampal Avoidance for Brain Metastases
A study testing Hippocampal avoidance WBRT and Conformal WBRT in people with Metastatic Malignant Neoplasm to Brain, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
Brain metastases are the most common brain tumors in adults. It is estimated that around 10-30% of cancer patients would develop brain metastases during the course of their illness. Whole brain radiotherapy (WBRT) is the treatment of choice for the majority of patients with brain metastases. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Metastatic Malignant Neoplasm to Brain
- What is being tested?
- Hippocampal avoidance WBRT and Conformal WBRT
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteTaiwan
- Study dates
- 3 Mar 2015to Dec 2020
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- To be eligible for inclusion, patients must fulfill the following criteria:
- Patients with a histologic diagnosis of non-hematopoietic malignancy and radiographic evidence of brain metastases
- Patients with brain metastasis outside a 5-mm margin around either hippocampus on gadolinium contrast enhanced MRI obtained within 30 days prior to registration
- Patients with brain metastasis who have not been or will not be treated with stereotactic radiosurgery (SRS) or have received SRS for≤ 5 intracranial metastatic lesions
- No evidence of leptomeningeal metastasis on gadolinium-enhanced MRI within 30 days prior registration
- Age ≥ 20 years
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- Karnofsky Performance Status ≥ 60%
- Life expectancy of ≥ 4 months.
- Women of childbearing potential and male participants must practice adequate contraception
- Patients must be able to comply with the study protocol and follow-up schedules and provide study- specific informed consent
Who cannot join
- Patients fulfill any of the following criteria will be excluded from this trial
- Prior radiotherapy to brain or SRS to > 5 intracranial metastatic lesion(s) or the biological equivalent dose in 2-Gy fractions was greater than 7.3 Gy to 40% of the volume of bilateral hippocampus from prior SRS
- Serum creatinine > 2.0 mg/dL within 30 days prior registration
- Contraindication to MRI such as implanted metal devices or foreign bodies, severe claustrophobia
- Patients with leptomeningeal metastases
- Severe, active comorbidities which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and adverse events of the protocol, or limit compliance with study requirements, defined as follows:
Show all 16Show fewer
- Uncontrolled active infection requiring intravenous antibiotics at the time of registration
- Transmural myocardial infarction ≤ 6 months prior to registration
- Unstable angina or congestive heart failure requiring hospitalization ≤ 6 months prior to registration
- Life-threatening uncontrolled clinically significant cardiac arrhythmias
- Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects
- Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registration
- Uncontrolled psychiatric disorder
- Uncontrolled, clinically significant cardiac arrhythmias
- Will receive any other investigational agent or chemotherapy and/or target therapies during WBRT
- Women of childbearing potential and male participants who are sexually active and not willing/able to use medically acceptable forms of contraception; this exclusion is necessary because the radiation treatment involved in this study may be significantly teratogenic
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Neurocognitive Outcome of Conformal Whole Brain Radiotherapy With or Without Hippocampal Avoidance for Brain Metastases: A Phase II Single Blind Randomized Trial
Brain metastases are the most common brain tumors in adults. It is estimated that around 10-30% of cancer patients would develop brain metastases during the course of their illness.
Whole brain radiotherapy (WBRT) is the treatment of choice for the majority of patients with brain metastases. WBRT yields high radiologic response rate (27~56%) and is effective in rapid palliation of neurologic symptoms as well as prolongs time to neurocognitive function decline caused by intracranial lesions. By using conventional fractionation, 33% of patients developed late neurocognitive toxicity while memory impairment was the most common symptom. The incidence is even higher when a formal and sensitive neurocognitive assessment was prospectively evaluated. With more long-term survivors nowadays, it has become increasingly important to minimize neurocognitive function decline and maintain quality of life in patients with brain metastasis.
Read more
The function of hippocampus is cooperation in learning, consolidation and retrieval of information and essential for formation of new memories. Bilateral and unilateral radiation injury of the hippocampus is known to alter learning and memory formation. Several preclinical studies support the hypothesis of hippocampus-mediated cognitive dysfunction by ionizing radiation. Clinical studies show increase in radiation dose to hippocampus is associated with subsequent neurocognitive function impairment in adult and pediatric patients. Furthermore, the preliminary result of Radiation Therapy Oncology Group (RTOG) 0933 suggested hippocampal avoidance significant reduce the mean relative decline at 4 months from 30% in historical cohort with WBRT to 7% in experimental cohort.
Previous studies showed brain structures other than hippocampus are also associated with radiation-induced decline in neurocognitive function. There is presence of placebo effect for interventions seeking improvement in neurocognitive function. In present study, a single blind randomized phase II trial is designed to investigate the effectiveness of neurocognitive function preservation using conformal WBRT with or without hippocampal avoidance.
Read the detailed description
This is a single institutional, randomized phase II study to assess the neurocognitive outcome of conformal WBRT with or without hippocampal avoidance in patients with multiple brain metastases.
Patients will be randomly assigned 1:1 to receive conformal WBRT with or without hippocampal avoidance using permuted blocks within strata that are defined by Graded Prognostic Assessment (GPA) score and baseline neurocognitive status. All patients and co-investigators except the principal investigator and attending radiation oncologists will be blinded for treatment groups.
The whole brain planning target volume (PTV) will receive 30 Gy in 10 fractions. Treatment will be delivered once daily, 5 fractions per week, over 2 to 2.5 weeks. Breaks in treatment should be minimized.
Hippocampal Avoidance WBRT:
The dose is prescribed such as 90% of cranial content PTV is covered by the prescription dose.
Maximum dose to 2% of the PTV (D2%) is 37.5 Gy, and minimum dose to 98% of the PTV (D98%) is 25 Gy. Minimum dose to 100% of the hippocampal avoidance regions is 10 Gy, and dose to any point within the hippocampal avoidance regions cannot exceed 17 Gy.
Conformal WBRT:
The dose is prescribed such as 95% of cranial content PTV is covered by the prescription dose.
Maximum dose to 1% of the PTV (D1%) is 36 Gy, and minimum dose to 99% of the PTV (D99%) is 27 Gy.
Follow-up \& Assessment
Side effect evaluation:
- Acute (≤ 90 days from WBRT start) toxicities (CTCAE ver.4)
- Late (> 90 days from WBRT start) toxicities (CTCAE ver.4)
Functional evaluation: at baseline, 2-, 4- ,and 6-month, every 3 months for 12 months until intracranial disease progression or death after WBRT
- Neurocognitive function
- Self-reported cognitive functioning (two items from EORTC Quality of Life Questionnaire-C30 Taiwan)
- Health-related quality of life specific for brain neoplasms (EORTC Quality of Life Questionnaire-Brain Neoplasm Taiwan)
Efficacy evaluation:
- Follow-up brain MRI at 4-, 9- ,and 12-month until intracranial disease progression, or death.
- Overall survival
- Conditions
- Metastatic Malignant Neoplasm to Brain
- Being tested
- Hippocampal avoidance WBRT, Conformal WBRT
- Keywords
- Brain Metastases, Whole Brain Radiotherapy, Neurocognitive function
- Medical subject headings
- Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hippocampal avoidance WBRTRadiation
Conformal Whole Brain Radiotherapy 30 Gy in 10 fractions with Hippocampal Avoidance using Intensity modulated radiotherapy, Volumetric arc therapy, or Tomotherapy
Conformal WBRTRadiation
Conformal Whole Brain Radiotherapy 30 Gy in 10 fractions with Hippocampal Avoidance using Intensity modulated radiotherapy, Volumetric arc therapy, or Tomotherapy
| Study group | Role | What they receive |
|---|---|---|
| Hippocampal avoidance WBRT | Experimental | Conformal whole brain radiotherapy with hippocampal avoidance Receives: Radiation: Hippocampal avoidance WBRT |
| Conformal WBRT | Active comparator | Conformal whole brain radiotherapy without hippocampal avoidance Receives: Radiation: Conformal WBRT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hopkins Verbal Learning Test-Revised (HVTL-R) delayed recall score
Decline in Hopkins Verbal Learning Test-Revised (HVTL-R) delayed recall score from baseline to 4 months after the start of conformal whole brain radiotherapy with or without hippocampal avoidance for brain metastases
Measured: At 4 months after radiotherapy
Secondary outcomes (6)
Neurocognitive function by a standardized neurocognitive battery
Evaluate neurocognitive function by a standardized neurocognitive battery (HVTL-R, Trail Making Test Part A \& B, forward \& backward Digit Span).
Measured: at 1, 2, 4, 6, 9, 12 months after radiotherapy, and then every 3 months until date of death from any cause, assessed up to 24 months
Patient reported outcome (Quality of Life questionnaire)
EORTC Quality of Life-Core 30 questionnaire module and Quality of Life questionnaire -brain
Measured: at 1, 2, 4, 6, 9, 12 months after radiotherapy, and then every 3 months until date of death from any cause, assessed up to 24 months
Acute toxicity (Common Toxicity Criteria for Adverse Events version 4)
Common Toxicity Criteria for Adverse Events version 4
Measured: From date of radiotherapy until 90 days after radiotherapy starts
Late toxicity (Common Toxicity Criteria for Adverse Events version 4)
Common Toxicity Criteria for Adverse Events version 4
Measured: From 90 days after radiotherapy starts until the date of death from any cause, up to 60 months
Intracranial progression (Number of participant with intracranial progression on MRI of brain)
Number of participant with intracranial progression on MRI of brain
Measured: From date of enrolment until the date of first documented intracranial progression or date of death from any cause, whichever came first, assessed up to 60 months
Overall survival
Number of patients died
Measured: From date of enrollment until the date of death from any cause, assessed up to 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2015 (estimated)
- Study start3 Mar 2015
- Primary completionJun 2019
- Study completionDec 2020 (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 Metastatic Malignant Neoplasm to BrainStudies of the same condition, open and under way.
- More trials run by National Taiwan University 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Feng-Ming Hsu, MD, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02393131
- Sponsor's protocol ID
- 201412029RINB
- Status last verified
- Mar 2019
- First submitted
- 23 Feb 2015
- Last updated
- 19 Jul 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Yang WC, Chen YF, Yang CC, Wu PF, Chan HM, Chen JL, Chen GY, Cheng JC, Kuo SH, Hsu FM. Hippocampal avoidance whole-brain radiotherapy without memantine in preserving neurocognitive function for brain metastases: a phase II blinded randomized trial. Neuro Oncol. 2021 Mar 25;23(3):478-486. doi: 10.1093/neuonc/noaa193.
PubMed 32789503
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neurocognitive Outcome of Conformal Whole Brain Radiotherapy With or Without Hippocampal Avoidance for Brain Metastases: A Phase II Single Blind Randomized Trial
- ClinicalTrials.gov ID
- NCT02393131
- Acronym / sponsor ID
- 201412029RINB
- Conditions
- Metastatic Malignant Neoplasm to Brain
- Keywords
- Brain Metastases, Whole Brain Radiotherapy, Neurocognitive function
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 3 Mar 2015 (actual)
- Primary completion
- Jun 2019 (actual)
- Study completion
- Dec 2020 (estimated)
- First posted
- 19 Mar 2015 (estimated)
- 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.
Brain metastases are the most common brain tumors in adults. It is estimated that around 10-30% of cancer patients would develop brain metastases during the course of their illness.
Whole brain radiotherapy (WBRT) is the treatment of choice for the majority of patients with brain metastases. WBRT yields high radiologic response rate (27~56%) and is effective in rapid palliation of neurologic symptoms as well as prolongs time to neurocognitive function decline caused by intracranial lesions. By using conventional fractionation, 33% of patients developed late neurocognitive toxicity while memory impairment was the most common symptom. The incidence is even higher when a formal and sensitive neurocognitive assessment was prospectively evaluated. With more long-term survivors nowadays, it has become increasingly important to minimize neurocognitive function decline and maintain quality of life in patients with brain metastasis.
The function of hippocampus is cooperation in learning, consolidation and retrieval of information and essential for formation of new memories. Bilateral and unilateral radiation injury of the hippocampus is known to alter learning and memory formation. Several preclinical studies support the hypothesis of hippocampus-mediated cognitive dysfunction by ionizing radiation. Clinical studies show increase in radiation dose to hippocampus is associated with subsequent neurocognitive function impairment in adult and pediatric patients. Furthermore, the preliminary result of Radiation Therapy Oncology Group (RTOG) 0933 suggested hippocampal avoidance significant reduce the mean relative decline at 4 months from 30% in historical cohort with WBRT to 7% in experimental cohort.
Previous studies showed brain structures other than hippocampus are also associated with radiation-induced decline in neurocognitive function. There is presence of placebo effect for interventions seeking improvement in neurocognitive function. In present study, a single blind randomized phase II trial is designed to investigate the effectiveness of neurocognitive function preservation using conformal WBRT with or without hippocampal avoidance.
Detailed description
This is a single institutional, randomized phase II study to assess the neurocognitive outcome of conformal WBRT with or without hippocampal avoidance in patients with multiple brain metastases.
Patients will be randomly assigned 1:1 to receive conformal WBRT with or without hippocampal avoidance using permuted blocks within strata that are defined by Graded Prognostic Assessment (GPA) score and baseline neurocognitive status. All patients and co-investigators except the principal investigator and attending radiation oncologists will be blinded for treatment groups.
The whole brain planning target volume (PTV) will receive 30 Gy in 10 fractions. Treatment will be delivered once daily, 5 fractions per week, over 2 to 2.5 weeks. Breaks in treatment should be minimized.
Hippocampal Avoidance WBRT:
The dose is prescribed such as 90% of cranial content PTV is covered by the prescription dose.
Maximum dose to 2% of the PTV (D2%) is 37.5 Gy, and minimum dose to 98% of the PTV (D98%) is 25 Gy. Minimum dose to 100% of the hippocampal avoidance regions is 10 Gy, and dose to any point within the hippocampal avoidance regions cannot exceed 17 Gy.
Conformal WBRT:
The dose is prescribed such as 95% of cranial content PTV is covered by the prescription dose.
Maximum dose to 1% of the PTV (D1%) is 36 Gy, and minimum dose to 99% of the PTV (D99%) is 27 Gy.
Follow-up \& Assessment
Side effect evaluation:
- Acute (≤ 90 days from WBRT start) toxicities (CTCAE ver.4)
- Late (> 90 days from WBRT start) toxicities (CTCAE ver.4)
Functional evaluation: at baseline, 2-, 4- ,and 6-month, every 3 months for 12 months until intracranial disease progression or death after WBRT
- Neurocognitive function
- Self-reported cognitive functioning (two items from EORTC Quality of Life Questionnaire-C30 Taiwan)
- Health-related quality of life specific for brain neoplasms (EORTC Quality of Life Questionnaire-Brain Neoplasm Taiwan)
Efficacy evaluation:
- Follow-up brain MRI at 4-, 9- ,and 12-month until intracranial disease progression, or death.
- Overall survival
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hippocampal avoidance WBRT | Experimental | Radiation: Hippocampal avoidance WBRTConformal whole brain radiotherapy with hippocampal avoidance |
| Conformal WBRT | Active comparator | Radiation: Conformal WBRTConformal whole brain radiotherapy without hippocampal avoidance |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Patients with a histologic diagnosis of non-hematopoietic malignancy and radiographic evidence of brain metastases
- Patients with brain metastasis outside a 5-mm margin around either hippocampus on gadolinium contrast enhanced MRI obtained within 30 days prior to registration
- Patients with brain metastasis who have not been or will not be treated with stereotactic radiosurgery (SRS) or have received SRS for≤ 5 intracranial metastatic lesions
- No evidence of leptomeningeal metastasis on gadolinium-enhanced MRI within 30 days prior registration
- Age ≥ 20 years
Key exclusion criteria (16 listed)
- Patients fulfill any of the following criteria will be excluded from this trial
- Prior radiotherapy to brain or SRS to > 5 intracranial metastatic lesion(s) or the biological equivalent dose in 2-Gy fractions was greater than 7.3 Gy to 40% of the volume of bilateral hippocampus from prior SRS
- Serum creatinine > 2.0 mg/dL within 30 days prior registration
- Contraindication to MRI such as implanted metal devices or foreign bodies, severe claustrophobia
- Patients with leptomeningeal metastases
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 |
|---|---|---|
| Hippocampal avoidance WBRTConformal Whole Brain Radiotherapy 30 Gy in 10 fractions with Hippocampal Avoidance using Intensity modulated radiotherapy, Volumetric arc therapy, or Tomotherapy | Radiation | Hippocampal avoidance WBRT |
| Conformal WBRTConformal Whole Brain Radiotherapy 30 Gy in 10 fractions with Hippocampal Avoidance using Intensity modulated radiotherapy, Volumetric arc therapy, or Tomotherapy | Radiation | Conformal WBRT |
Primary outcome
Hopkins Verbal Learning Test-Revised (HVTL-R) delayed recall score
Time frame: At 4 months after radiotherapy
Decline in Hopkins Verbal Learning Test-Revised (HVTL-R) delayed recall score from baseline to 4 months after the start of conformal whole brain radiotherapy with or without hippocampal avoidance for brain metastases
6 secondary outcomes
Neurocognitive function by a standardized neurocognitive battery
Time frame: at 1, 2, 4, 6, 9, 12 months after radiotherapy, and then every 3 months until date of death from any cause, assessed up to 24 months
Patient reported outcome (Quality of Life questionnaire)
Time frame: at 1, 2, 4, 6, 9, 12 months after radiotherapy, and then every 3 months until date of death from any cause, assessed up to 24 months
Acute toxicity (Common Toxicity Criteria for Adverse Events version 4)
Time frame: From date of radiotherapy until 90 days after radiotherapy starts
Late toxicity (Common Toxicity Criteria for Adverse Events version 4)
Time frame: From 90 days after radiotherapy starts until the date of death from any cause, up to 60 months
Intracranial progression (Number of participant with intracranial progression on MRI of brain)
Time frame: From date of enrolment until the date of first documented intracranial progression or date of death from any cause, whichever came first, assessed up to 60 months
Overall survival
Time frame: From date of enrollment until the date of death from any cause, assessed up to 60 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2019.
- Derived from this study: PubMed 32789503Yang WC, Chen YF, Yang CC, Wu PF, Chan HM, Chen JL, Chen GY, Cheng JC, Kuo SH, Hsu FM. Hippocampal avoidance whole-brain radiotherapy without memantine in preserving neurocognitive function for brain metastases: a phase II blinded randomized trial. Neuro Oncol. 2021 Mar 25;23(3):478-486. doi: 10.1093/neuonc/noaa193.
- 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.
Feng-Ming Hsu, MD principal investigator
National Taiwan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hippocampal avoidance WBRT and Conformal WBRT in people with Metastatic Malignant Neoplasm to Brain, run by National Taiwan University 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 10 inclusion and 16 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 19 Jul 2019. 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.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hopkins Verbal Learning Test-Revised (HVTL-R) delayed recall score (time frame: At 4 months after radiotherapy). 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 NCT02393131, 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 19 Jul 2019.