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Brain MetastasesPhase 2NCT04452084

Phase 2 Trial in Multiple Brain Metastases Outcomes With HA-SIB-WBRT

A Phase 2 study testing HA-WBRT and HA-SIB-WBRT in people with Brain Metastases, run by National Cancer Centre, Singapore at 1 site in Singapore.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Recently, the 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 it gives better neurocognitive preservation compared to historical whole brain radiotherapy controls. Read more about this study

Who is it for?
Ages 21 to 80 years
Conditions the study is for
Brain Metastases
What is being tested?
HA-WBRT and HA-SIB-WBRT
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
42 participants
Where
1 siteSingapore
Study dates
15 Jun 2020to 1 Jul 2024
Phase
Phase 2
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 21 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 21-80 years old patients with radiological confirmed brain metastases (5-25 lesions)
  • Histologically proven malignancy of primary cancer
  • ECOG performance status ≤ 2
  • Maximum lesion or cavity size ≤ 5cm
  • For patients with large (≥ 3cm) lesions, a neurosurgical consult is recommended as the risk of cerebral oedema and hydrocephalus is higher with RT. A Ventricular-peritoneal shunt/ surgical excision may be required prior to planning of RT
  • If brain surgery or other invasive procedures are performed, the treatment can only begin at least 2-weeks post-procedure
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  • Life expectancy of at least 6 months
  • Negative serum pregnancy test within 14 days prior to registration for women of childbearing potential
  • Women of childbearing potential and male participants who are sexually active must agree to use a medically effective means of birth control throughout protocol treatment
  • Not recommended or does not want Stereotactic Radiosurgery (SRS)
  • Agrees to be randomised to either HA-WBRT or HA-SIB-WBRT

Who cannot join

  • Prior whole brain radiotherapy
  • o Prior SRS is not an exclusion. Details of treatment must be recorded.
  • Concurrent systemic cytotoxic treatment.
  • o If patient is on systemic treatment a treatment break of at least 7 days for immunotherapy or chemotherapy and 3 days for targeted therapy is required before and after radiotherapy.
  • Leptomeningeal disease
  • Extensive extracranial disease, not controlled by systemic treatment
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  • Severe, active co-morbidity, defined as follows:
  • Major medical or psychiatric illness, which in the investigator's opinion would interfere with the completion of therapy and follow up or with full understanding of the risks and potential complications of the therapy;
  • Unstable angina and/or uncontrolled congestive heart failure;
  • Myocardial infarction within the last 6 months;
  • Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration; note that patients switched from IV antibiotics and currently on oral antibiotics whose infection is assessed to be adequately treated or controlled are eligible.
  • Chronic Obstructive Pulmonary Disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy within 30 days prior to registration;
  • Acquired Immune Deficiency Syndrome (AIDS) based upon current CDC definition; note, however, that HIV testing is not required for entry into this protocol. The need to exclude patients with AIDS from this protocol is necessary because the treatments involved in this protocol may be significantly immunosuppressive.
  • Dementia, ongoing psychotic episodes or moderate-severe depression (PHQ-9).
  • Recent stroke in the past 3 months
  • Pregnancy or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception;
  • ECOG performance status >2 despite a duration of high dose steroids
  • Symptomatic brain metastases limiting ADLs
  • Rapid brain progression
  • Patients unable to give informed consent
  • Total tumour planning target volume (PTV) >60cc
  • Radiological evidence of hydrocephalus
  • Contraindication to Gadolinium contrast-enhanced MRI brain
  • Patients who are unable to meet expected follow-up schedule (e.g. non-resident patients)
  • Patients with diagnoses of small cell carcinoma, lymphoma or primary brain tumour

Trial locations and contacts

1 site in 1 country.

Singapore1 site

  • National Cancer Center Singapore

    Singapore, 168583

Other trials in Singapore

About this study

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

Recently, the 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 it gives better neurocognitive preservation compared to historical whole brain radiotherapy controls. There is however 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, gives 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 integrate boost (SIB) dose to lesions whilst minimising doses to the hippocampus to potentially improve brain tumour control and preserve cognitive outcomes (HA-SIB-WBRT).

The Investigators believe that the SIB in HA-SIB-WBRT (experimental) will result in better functional and survival outcomes compared to HA-WBRT (control). Patients who are fit, have multiple brain metastases (5-25 lesions) and reasonable life expectancy (>6 months) will be recruited from NCCS over 2 years. Patients will be followed up the over the following year with imaging, toxicity data, quality of life, activities of daily living and cognitive measurements at set time points. The results will be compared across the 2 arms.

Patients with brain metastases are living longer. Maintaining functional independence and brain metastases control is thus increasingly important. Improved radiotherapy treatment techniques could provide better control and survival outcomes whilst maintain QoL and functional capacity.

Being tested
HA-WBRT, HA-SIB-WBRT
Keywords
Whole Brain Radiotherapy, Brain metastases, Cognitive outcomes
Medical subject headings
Brain Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • HA-WBRTRadiation

    The accepted standard HA-WBRT doses in the control arm are 30Gy in 10 fractions.

  • HA-SIB-WBRTRadiation

    The doses selected for experimental HA-SIB-WBRT arm are 30Gy in 10 fractions to the whole brain with 40 to 45Gy in 10 fraction SIB doses to tumours.

Study groups in NCT04452084
Study groupRoleWhat they receive
ControlActive comparatorNot described
Receives: Radiation: HA-WBRT
Experimental ProcedureExperimentalNot described
Receives: Radiation: HA-SIB-WBRT

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Target lesion progression

    Measured: From time of randomisation to target lesion progression, up to 6 months after last day of radiotherapy.

Secondary outcomes (5)

  1. Time to symptomatic brain metastases

    Measured: From time of randomisation to symptomatic brain progression, up to 12 months after last day of radiotherapy.

  2. Incidences of treatment-emergent adverse events (AE)

    Identified and graded using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 criteria.

    Measured: From time of randomisation to 12 months after last day of radiotherapy.

  3. Overall Survival

    Measured: From time of randomisation to death from any cause, up to 12 months after last day of radiotherapy.

  4. Progression Free Survival

    Measured: From time of randomisation to overall progression, up to 12 months after last day of radiotherapy.

  5. Cognitive function

    Assessed using Hopkins Verbal Learning Test

    Measured: From time of randomisation to 12 months after last day of radiotherapy.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Jun 2020
  2. Study start15 Jun 2020
  3. Primary completion1 Jul 2024
  4. Study completion1 Jul 2024

Resources

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
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
42 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04452084
Sponsor's protocol ID
HA-SIB-WBRT
Status last verified
Mar 2025
First submitted
25 Jun 2020
Last updated
20 Mar 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Chia BSH, Leong JY, Ong ALK, Lim C, Poon SH, Chua MLK, Chua KLM, Kusumawidjaja G, Chua ET, Wong FY, Lee TS. 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. BMC Cancer. 2020 Oct 30;20(1):1045. doi: 10.1186/s12885-020-07565-y.

    PubMed 33126867

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing HA-WBRT and HA-SIB-WBRT in people with Brain Metastases, run by National Cancer Centre, Singapore at 1 site in Singapore.

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 11 inclusion and 25 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: finished, as of the sponsor's last update on 20 Mar 2025. 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 Singapore. 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 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.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Target lesion progression (time frame: From time of randomisation to target lesion progression, up to 6 months after last day of 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 NCT04452084, 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 20 Mar 2025.

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