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Neoplasm MetastasisWBRTvsSRSNCT02353000

Whole Brain Radiotherapy (WBRT) Versus Stereotactic Radiosurgery (SRS) for 4 Upto 10 Brain Metastases

A study testing Stereotactic Radiosurgery and Whole Brain Radiotherapy in people with Neoplasm Metastasis, run by Maastricht Radiation Oncology at 7 sites in Netherlands.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

Recently stereotactic radiosurgery (SRS) in 5 up to 10 brain metastases showed to have equal survival as in 2 up to 4 brain metastases. Whole brain radiotherapy (WBRT) is currently the gold standard for patients with more than 3 brain metastases, but has significant side effects. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Neoplasm Metastasis
What is being tested?
Stereotactic Radiosurgery and Whole Brain Radiotherapy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
31 participants
Where
7 sitesNetherlands
Study dates
Jul 2016to Dec 2019
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Minimal 4 up to a maximum of 10 BM on diagnostic MRI scan
  • Max diameter of single GTV 2.5cm
  • Max cumulative GTV of 30cm3
  • Karnofsky performance status ≥ 70
  • Any solid primary tumour. Small cell lung carcinoma, germinoma, and lymphoma are excluded
  • Ability to provide written informed consent

Who cannot join

  • Contra-indication for MRI
  • Prior treatment for BM (i.e. surgery, SRS or WBRT)
  • Concurrent use of systemic therapy
  • Maximum cumulative GTV of more than 30cm3 on planning-MRI
  • More than 10 BM on planning-MRI
  • A brainstem metastasis with a PTV of more than 20 cm3

Trial locations and contacts

7 sites in 1 country.

7 sites in 1 country

Netherlands7 sites

  • VUmc

    Amsterdam, 1081HV

  • AMC

    Amsterdam, 1105AZ

  • ZRTI

    Flushing, 4382EK

  • Maastricht Radiation Oncology (MAASTRO clinic)

    Maastricht, 6202 AZ

  • Erasmus MC

    Rotterdam, 3015CE

  • Haaglanden MC

    The Hague, 2262BA

  • Instituut Verbeeten

    Tilburg, 5042BS

Other trials in Netherlands

About this study

Official title: Whole Brain Radiotherapy vs. Stereotactic Radiosurgery for 4 - 10 Brain Metastases:a Phase III Randomized Multicenter Trial

Recently stereotactic radiosurgery (SRS) in 5 up to 10 brain metastases showed to have equal survival as in 2 up to 4 brain metastases. Whole brain radiotherapy (WBRT) is currently the gold standard for patients with more than 3 brain metastases, but has significant side effects. In this prospective randomized phase III trial WBRT is compared to SRS for patients with 4 up to 10 BM.

Read the detailed description

Dutch guideline advices stereotactic radiosurgery (SRS) for patients with 1 up to 3 brain metastases (BM) and whole brain radiotherapy (WBRT) for patients with 4 or more BM. The interim analysis from the QUARTZ study showed that WBRT did not provide benefit in quality of life nor survival over best supportive care. WBRT has significant side effects, such as hair loss, fatigue, and cognitive dysfunction which may impair quality of life. A recently published study showed that SRS in patients with 5 up to 10 BM had a comparable survival to patients treated with 2 up to 4 BM. Many systemic therapies do not have a satisfactory intracranial response, because of the blood-brain barrier. The potential advantages of SRS i.e, limiting radiation doses to the uninvolved brain and a high rate of local tumour control by just a single treatment. Next logic step would be to compare WBRT with SRS alone in patients with 4-10 BM and evaluate whether SRS is superior to WBRT with regard to QOL.

Being tested
Stereotactic Radiosurgery, Whole Brain Radiotherapy
Medical subject headings
Neoplasm Metastasis

What participants receive

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

  • Stereotactic RadiosurgeryRadiation

    Stereotactic Radiosurgery for patients with 4 up to 10 brain metastases

  • Whole Brain RadiotherapyRadiation

    Whole Brain Radiotherapy for patients with 4 up to 10 brain metastases

Study groups in NCT02353000
Study groupRoleWhat they receive
Stereotactic RadiosurgeryExperimentalStereotactic Radiosurgery for patients with 4 up to 10 brain metastases:
Receives: Radiation: Stereotactic Radiosurgery
Whole Brain RadiotherapyOtherWhole Brain Radiotherapy for patients with 4 up to 10 brain metastases:
Receives: Radiation: Whole Brain Radiotherapy

What is being measured

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

  1. Quality of life in patients with 4 - 10 brain metastases comparing WBRT and SRS

    Quality of life is measured by the EQ-5D-5L, a descriptive system of health-related quality of life states consisting of five dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression)

    Measured: Change in quality of life measured from baseline to 3 months after radiotherapy

Secondary outcomes (5)

  1. Overall survival steroid use (mg), toxicity including hair loss and fatigue.

    Overall survival

    Measured: 1 year

  2. Time that patient is functioning independently (Karnofsky ≥ 70)

    Time that patient is functioning independently (Karnofsky ≥ 70)

    Measured: Change in Karnofsky index from baseline to 3 months after radiotherapy

  3. Steroid use

    Steroid use in mg over time

    Measured: Change in steroid use from baseline to 3 months after radiotherapy

  4. Toxicity measured by hair loss and fatigue

    Toxicity measured by hair loss and fatigue using CTCAE version 4.0

    Measured: Change in toxicity from baseline to 3 months after radiotherapy

  5. Degree of independence

    Degree of independence of patients using the Barthel index

    Measured: Change in independence from baseline to 3 months after radiotherapy

Timeline

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

  1. First posted2 Feb 2015 (estimated)
  2. Study startJul 2016
  3. Primary completionApr 2019
  4. Study completionDec 2019

Why it stopped: Unable to achieve accrural within anticipated timeframe

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 N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
31 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02353000
Sponsor's protocol ID
01-2015
Acronym
WBRTvsSRS
Status last verified
May 2020
First submitted
16 Jan 2015
Last updated
1 Jun 2020
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Publications

  • Gijtenbeek JM, Ho VK, Heesters MA, Lagerwaard FJ, de Graeff A, Boogerd W. [Practice guideline 'Brain metastases' (revision)]. Ned Tijdschr Geneeskd. 2011;155(52):A4141. Dutch.

    PubMed 22217243

  • Yamamoto M, Serizawa T, Shuto T, Akabane A, Higuchi Y, Kawagishi J, Yamanaka K, Sato Y, Jokura H, Yomo S, Nagano O, Kenai H, Moriki A, Suzuki S, Kida Y, Iwai Y, Hayashi M, Onishi H, Gondo M, Sato M, Akimitsu T, Kubo K, Kikuchi Y, Shibasaki T, Goto T, Takanashi M, Mori Y, Takakura K, Saeki N, Kunieda E, Aoyama H, Momoshima S, Tsuchiya K. Stereotactic radiosurgery for patients with multiple brain metastases (JLGK0901): a multi-institutional prospective observational study. Lancet Oncol. 2014 Apr;15(4):387-95. doi: 10.1016/S1470-2045(14)70061-0. Epub 2014 Mar 10.

    PubMed 24621620

  • Zindler JD, Rodrigues G, Haasbeek CJ, De Haan PF, Meijer OW, Slotman BJ, Lagerwaard FJ. The clinical utility of prognostic scoring systems in patients with brain metastases treated with radiosurgery. Radiother Oncol. 2013 Mar;106(3):370-4. doi: 10.1016/j.radonc.2013.01.015. Epub 2013 Mar 20.

    PubMed 23522151

  • Langley RE, Stephens RJ, Nankivell M, Pugh C, Moore B, Navani N, Wilson P, Faivre-Finn C, Barton R, Parmar MK, Mulvenna PM; QUARTZ Investigators. Interim data from the Medical Research Council QUARTZ Trial: does whole brain radiotherapy affect the survival and quality of life of patients with brain metastases from non-small cell lung cancer? Clin Oncol (R Coll Radiol). 2013 Mar;25(3):e23-30. doi: 10.1016/j.clon.2012.11.002. Epub 2012 Dec 2.

    PubMed 23211715

  • Hartgerink D, Bruynzeel A, Eekers D, Swinnen A, Hurkmans C, Wiggenraad R, Swaak-Kragten A, Dieleman E, van der Toorn PP, van Veelen L, Verhoeff JJC, Lagerwaard F, de Ruysscher D, Lambin P, Zindler J. Quality of life among patients with 4 to 10 brain metastases after treatment with whole-brain radiotherapy vs. stereotactic radiotherapy: a phase III, randomized, Dutch multicenter trial. Ann Palliat Med. 2022 Apr;11(4):1197-1209. doi: 10.21037/apm-21-1545. Epub 2021 Nov 18.

    PubMed 34806396

  • Zindler JD, Bruynzeel AME, Eekers DBP, Hurkmans CW, Swinnen A, Lambin P. Whole brain radiotherapy versus stereotactic radiosurgery for 4-10 brain metastases: a phase III randomised multicentre trial. BMC Cancer. 2017 Jul 25;17(1):500. doi: 10.1186/s12885-017-3494-z.

    PubMed 28743240

Questions about this trial

What is this clinical trial studying?

A study testing Stereotactic Radiosurgery and Whole Brain Radiotherapy in people with Neoplasm Metastasis, run by Maastricht Radiation Oncology at 7 sites in Netherlands.

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 6 inclusion and 6 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: stopped early, as of the sponsor's last update on 1 Jun 2020. 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 Netherlands. 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?

The study was stopped early (reason given: Unable to achieve accrural within anticipated timeframe). 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?

Quality of life in patients with 4 - 10 brain metastases comparing WBRT and SRS (time frame: Change in quality of life measured from baseline to 3 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 NCT02353000, which also lists 6 linked publications.

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 Jun 2020; AzTrials last refreshed its copy on 8 Nov 2026.

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