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Brain MetastasesPhase 2HIPPONCT02147028

Hippocampal Sparing Whole Brain Radiotherapy vs Conventional Whole Brain Radiotherapy in Patients With Brain Metastases

A Phase 2 study testing Hippocampal sparing whole brain radiotherapy and Conventional whole brain radiotherapy in people with Brain Metastases, run by University College, London at 7 sites in United Kingdom.

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

The purpose of this study is to evaluate whether sparing the hippocampi during whole brain radiotherapy following neurosurgery or stereotactic radiosurgery in patients with brain metastases from a systemic tumour helps preserve brain function. Read more about this study

Who is it for?
Ages 16 years and older
Conditions the study is for
Brain Metastases
What is being tested?
Hippocampal sparing whole brain radiotherapy and Conventional whole brain radiotherapy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
23 participants
Where
7 sitesUnited Kingdom
Study dates
3 Aug 2016to 16 Feb 2021
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 16 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Age ≥ 16 years
  • Karnofsky Performance Status (KPS) ≥ 70
  • Brain metastases from systemic malignancy which has been histologically confirmed (from the primary or any metastatic site)
  • In total, at most 10 distinct brain metastases based on MRI imaging with contrast at any prior time-points
  • Each of the brain metastases to have been treated by complete or incomplete surgical excision or by SRS in line with UK SRS commissioning guidelines which in addition for STS treated patients means:
  • Patient selection for SRS by the appropriate MDT(s),
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  • No pressure symptoms which would be best relieved by surgery,
  • Life expectancy from extracranial disease greater than 6 months,
  • Gross tumour volume at time of SRS ≤ 20 cc.
  • Ability to comply with the following timelines:
  • Randomisation 1 - 4 weeks (+/- 3 days, but only acceptable if accounting for logistical issues) after neurosurgery or last SRS fraction,
  • Start of WBRT or HS-WBRT 4 - 6 weeks (+ 3 days, but only acceptable if accounting for logistical or planning treatment issues) after neurosurgery or last SRS fraction.
  • Ability to complete the NCF test battery (including ability to speak English).
  • Willing and able to give consent and to comply with treatment and follow up schedule.

Who cannot join

  • Metastases from small cell carcinoma from any site, haematological malignancy, or central nervous system malignancy,
  • Leptomeningeal metastases,
  • Contraindication to MRI imaging with contrast,
  • Prior radiotherapy to the brain (apart from a single course of SRS for brain metastases completed within 1-4 weeks (+/- 3 days) of randomisation and within 4-6 weeks (+3 days) of start of the HIPPO trial treatment),
  • Prior neurosurgery for brain metastases (apart from a single operation within 1-4 weeks (+/- 3 days) of randomisation and within 4-6 weeks (+3 days) of start of HIPPO trial treatment), except that one or more earlier operations not immediately preceding HIPPO trial entry will be allowed if:
  • there is no evidence of residual tumour at the resection site on contrast MRI imaging, or
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  • residual tumour at the resection site has been treated by SRS immediately prior to entering the HIPPO trial,
  • One or more metastases currently or previously within 5 mm of either hippocampus,
  • One or more metastases within the brainstem,
  • One or more SRS treated metastases in close proximity to critical normal organs, unless the local investigator is satisfied that the dose already received by the critical organ allows for subsequent delivery of the HIPPO protocol radiotherapy doses,
  • Disease specific graded prognostic assessment (DS-GPA) score ≤ 1.0 for any of the histologies for which DS-GPA has been defined,
  • Past medical history of dementia which is thought to be unrelated to the brain metastases,
  • Women of childbearing potential who are known to be pregnant, or are unwilling to use an acceptable method of contraception from the time of informed consent until completion of the course of radiotherapy.

Trial locations and contacts

7 sites in 1 country.

7 sites in 1 country

United Kingdom7 sites

  • University Hospitals Birmingham NHS Foundation Trust

    Birmingham, Greater London, N4 3SL

  • Addenbrooke's Hospital

    Cambridge

  • Royal Surrey County Hospital

    Guildford

  • Charing Cross Hospital

    London, W6 8RF

  • The Christie NHS Foundation Trust

    Manchester, M20 4BX

  • Nottingham University Hospitals

    Nottingham

  • Barking, Havering and Redbridge University Hospitals Nhs Trust

    Romford

Other trials in United Kingdom

About this study

Official title: A Randomized Phase II Trial of Hippocampal Sparing Versus Conventional Whole Brain Radiotherapy After Surgical Resection or Radiosurgery in Favourable Prognosis Patients With 1-10 Brain Metastases

The purpose of this study is to evaluate whether sparing the hippocampi during whole brain radiotherapy following neurosurgery or stereotactic radiosurgery in patients with brain metastases from a systemic tumour helps preserve brain function.

Being tested
Hippocampal sparing whole brain radiotherapy, Conventional whole brain radiotherapy
Keywords
whole brain RT, hippocampal sparing, 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 sparing whole brain radiotherapyRadiation

    30 Gy in 10 fractions hippocampal sparing whole brain radiotherapy will be administered by Helical Tomotherapy, IMRT, or VMAT

  • Conventional whole brain radiotherapyRadiation

    30 Gy in 10 fractions conventional whole brain radiotherapy will be administered

Study groups in NCT02147028
Study groupRoleWhat they receive
Hippocampal sparing whole brain RTExperimental30 Gy in 10 fractions hippocampal sparing whole brain radiotherapy will be administered by Helical Tomotherapy, IMRT, or VMAT
Receives: Radiation: Hippocampal sparing whole brain radiotherapy
Control: Conventional whole brain RTActive comparator30 Gy in 10 fractions conventional whole brain radiotherapy will be administered
Receives: Radiation: Conventional whole brain radiotherapy

What is being measured

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

  1. Total recall assessed using Hopkins Verbal Learning Test-Revised (HVTLR) at 4 months

    A decline in total recall will be assessed as being clinically significant if there is at least a 5 point decrease in total recall score at 4 months, compared to baseline [Jacobson 1991, Brandt 1998]

    Measured: 4 months after completion of WBRT or HS-WBRT

Secondary outcomes (7)

  1. Neurocognitive function

    NCF, using a 30-60 min test battery (Memory - HVLT-R, Wechsler Memory Scale (logical memory subtest), Rey figure test, Wechsler digit span; Attention - Test of Everyday Attention (map search subtest), Trail Making Test (Parts A and B); Language - Graded Naming Test); this may be revised in the light of forthcoming recommendations on NCF assessment in brain metastases trials by the RANO (Revised Assessment in Neuro-oncology) working party

    Measured: 2, 4, 6, 12 and 24 months after completion of WBRT or HS-WBRT

  2. Quality of life

    Quality of life will be assessed using EORTC QLQ C30 and BN20 and EuroQol EQ-5D questionnaires

    Measured: 2, 4, 6, 9, 12, 18 and 24 months after completion of WBRT or HS-WBRT

  3. Length of time functionally independent

    The duration of functional independence will be assessed as the time for which the Karnofsky Performance Status ≥ 70

    Measured: 2, 4, 6, 9, 12, 18 and 24 months after completion of WBRT or HS-WBRT

  4. Local control of surgery/SRS treated metastases, local and distant intracranial control (treated and new metastases), and disease control within the hippocampal regions

    Incidence of metastases within the perihippocampal region, local control, and intracranial control will be assessed on the basis of MRI imaging

    Measured: 2, 4, 6, 9, 12, 18 and 24 months after completion of WBRT or HS-WBRT

  5. Overall survival

    Date of death will be determined from the medical records, or from the GP

    Measured: followed up until 24 months after completion of WBRT or HS-WBRT

  6. Steroid and antiepileptic medication requirements

    Steroid and antiepileptic medication use will be recorded in patient diaries and assessed at clinic visits

    Measured: 2, 4, 6, 9, 12, 18 and 24 months after completion of WBRT or HS-WBRT

  7. Acute and late side effects of radiotherapy

    Acute and late side effects of radiotherapy will be assessed using NCI CTCAE scale v4.03

    Measured: 2, 4, 6, 9, 12, 18 and 24 months after completion of WBRT or HS-WBRT

Timeline

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

  1. First posted26 May 2014 (estimated)
  2. Study start3 Aug 2016
  3. Primary completionJun 2018
  4. Study completion16 Feb 2021

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
23 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02147028
Sponsor's protocol ID
UCL/12/0512
Other IDs
Cancer Research UK
Acronym
HIPPO
Status last verified
Feb 2021
First submitted
21 May 2014
Last updated
25 Feb 2021
Results posted
No
Data monitoring committee
No

Publications

  • Whitfield GA, Bulbeck H, Clifton-Hadley L, Edwards D, Jefferies S, Jenkinson MD, Griffin M, Handley J, Megias D, Sanghera P, Shaffer R, Short S, Wilson W. A Randomised Phase II Trial of Hippocampal Sparing Versus Conventional Whole Brain Radiotherapy After Surgical Resection or Radiosurgery in Favourable Prognosis Patients With 1-10 Brain Metastases. Clin Oncol (R Coll Radiol). 2024 Nov;36(11):681-689. doi: 10.1016/j.clon.2024.07.001. Epub 2024 Jul 4.

    PubMed 39030085

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Hippocampal sparing whole brain radiotherapy and Conventional whole brain radiotherapy in people with Brain Metastases, run by University College, London at 7 sites in United Kingdom.

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 14 inclusion and 13 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 25 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in United Kingdom. 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?

Total recall assessed using Hopkins Verbal Learning Test-Revised (HVTLR) at 4 months (time frame: 4 months after completion of WBRT or HS-WBRT). 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 NCT02147028, 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 25 Feb 2021.

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