Evidence map›Paper›PMID 33126867›Full record

ArticleBMC cancer2020

Randomised prospective phase II trial in multiple brain metastases comparing outcomes between hippocampal avoidance whole brain radiotherapy with or without simultaneous integrated boost: HA-SIB-WBRT study protocol.

Brendan Seng Hup Chia, Jing Yun Leong, Ashley Li Kuan Ong, Cindy Lim, Shi Hui Poon, Melvin Lee Kiang Chua, Kevin Lee Min Chua, Grace Kusumawidjaja, Eu Tiong Chua, Fuh Yong Wong and 1 more

Registry-linked trialOpen access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in BMC cancer, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04452084 (Randomised Prospective Phase 2 Trial in Multiple Brain Metastases Comparing Outcomes Between Hippocampal Avoidance Whole Brain Radiotherapy With or Without Simultaneous Integrated Boost), which is not on this map. Cited by 11 papers.

0numbers the graph read from it
0cells of the map it votes in
11citing papers in PubMed
1.0field-weighted citation impact, top 20% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04452084 phase2completednot on this map

Randomised Prospective Phase 2 Trial in Multiple Brain Metastases Comparing Outcomes Between Hippocampal Avoidance Whole Brain Radiotherapy With or Without Simultaneous Integrated Boost

TypeinterventionalSponsorNational Cancer Centre, SingaporeRan2020 to 2024Enrolled42ConditionsBrain MetastasesArmsHA-WBRT, HA-SIB-WBRT
3 · Its place in the literature

Who cites it

11 citing papers in PubMed, 13 citations in OpenAlex.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

11 authors at 4 institutions in 1 country.

Brendan Seng Hup ChiaDivision of Radiation Oncology, National Cancer Centre Singapore, 11 Hospital Crescent, Singapore, 169610, Singapore. brendan.chia.s.h@singhealth.com.sg.ORCID http://orcid.org/0000-0001-6804-3363
Jing Yun LeongDepartment of Adult Neuro-developmental Service, Institute of Mental Health Singapore, 10 Buangkok View, Singapore, 539747, Singapore.
Ashley Li Kuan OngDivision of Radiation Oncology, National Cancer Centre Singapore, 11 Hospital Crescent, Singapore, 169610, Singapore.
Cindy LimDivision of Clinical Trials and Epidemiological Sciences, National Cancer Centre Singapore, 11 Hospital Crescent, Singapore, 169610, Singapore.
Shi Hui PoonDepartment of Psychiatry, Singapore General Hospital, Outram Road, Singapore, 169608, Singapore.
Melvin Lee Kiang ChuaDivision of Radiation Oncology, National Cancer Centre Singapore, 11 Hospital Crescent, Singapore, 169610, Singapore.
Kevin Lee Min ChuaDivision of Radiation Oncology, National Cancer Centre Singapore, 11 Hospital Crescent, Singapore, 169610, Singapore.
Grace KusumawidjajaDivision of Radiation Oncology, National Cancer Centre Singapore, 11 Hospital Crescent, Singapore, 169610, Singapore.
Eu Tiong ChuaDivision of Radiation Oncology, National Cancer Centre Singapore, 11 Hospital Crescent, Singapore, 169610, Singapore.
Fuh Yong WongDivision of Radiation Oncology, National Cancer Centre Singapore, 11 Hospital Crescent, Singapore, 169610, Singapore.
Tih Shih LeeDepartment of Psychiatry, Singapore General Hospital, Outram Road, Singapore, 169608, Singapore.
National Cancer Centre Singapore · SGSingapore General Hospital · SGInstitute of Mental Health · SGSingHealth · SG

Funding

SingHealth Duke-NUS 08/FY2019/P2/13-A67
6 · The paper itself

Abstract

backgroundRecent evidence supports hippocampal avoidance with whole brain radiotherapy (HA-WBRT) as the recommended treatment option in patients with good prognosis and multiple brain metastases as this results in better neurocognitive preservation compared to whole brain radiotherapy. However, there is often poor tumour control with this technique due to the low doses given. Stereotactic Radiosurgery (SRS), a form of focused radiotherapy which is given to patients who have a limited number of brain metastases, delivers a higher radiation dose to the metastases resulting in better target lesion control. With improvements in radiation technology, advanced dose-painting techniques now allow a simultaneous integrated boost (SIB) dose to lesions whilst minimising doses to the hippocampus to potentially improve brain tumour control and preserve cognitive outcomes. This technique is abbreviated to HA-SIB-WBRT or HA-WBRT+SIB.

methodsWe hypothesise that the SIB in HA-SIB-WBRT (experimental arm) will result in better tumour control compared to HA-WBRT (control arm). This may also lead to better intracranial disease control as well as functional and survival outcomes. We aim to conduct a prospective randomised phase II trial in patients who have good performance status, multiple brain metastases (4-25 lesions) and a reasonable life expectancy (> 6 months). These patients will be stratified according to the number of brain metastases and randomised between the 2 arms. We aim for a recruitment of 100 patients from a single centre over a period of 2 years. Our primary endpoint is target lesion control. These patients will be followed up over the following year and data on imaging, toxicity, quality of life, activities of daily living and cognitive measurements will be collected at set time points. The results will then be compared across the 2 arms and analysed. DISCUSSION: Patients with brain metastases are living longer. Maintaining functional independence and intracranial disease control is thus increasingly important. Improving radiotherapy treatment techniques could provide better control and survival outcomes whilst maintaining quality of life, cognition and functional capacity. This trial will assess the benefits and possible toxicities of giving a SIB to HA-WBRT.

trial registrationClinicaltrials.gov identifier: NCT04452084 . Date of registration 30th June 2020.

Indexed as

Quality of LifeActivities of Daily LivingAdultAgedAged, 80 and overBrain NeoplasmsCase-Control StudiesClinical Trials, Phase II as TopicCranial IrradiationDose Fractionation, RadiationFemaleFollow-Up StudiesHippocampusHumansMaleMiddle AgedBrain metastasesHippocampal-avoidance whole brain radiotherapyStudy protocolWhole brain radiotherapy

Identifiers

PMID33126867
PMCPMC7602352
OpenAlexW3096450661

What OpenQuestion holds

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LicenceCC BY
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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.