Brain MetastasesSAFESTEREONCT05346367
Improving Therapeutic Ratio With Hypo Fractionated Stereotactic Radiotherapy for Brain Metastases
A study testing SRT and fSRT in people with Brain Metastases, run by Haaglanden Medical Centre at 1 site in Netherlands.
Trial summary
Randomized phase II trial. The study aims to investigate a different and potentially safer radio therapeutic treatment method for brain metastases. The current standard of stereotactic radiotherapy (SRT) in one or three fractions is compared to fractionated stereotactic radiotherapy (fSRT) in five fractions. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Brain Metastases
- What is being tested?
- SRT and fSRT
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 1 siteNetherlands
- Study dates
- 18 Jul 2022to Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Age ≥ 18 years
- At least one brain metastasis of large cell cancer suitable for SRT
- Karnofsky Performance Status ≥ 70
- Ability to provide written informed consent
- New brain metastases during follow-up after surgery allowed (when outside of resection cavity area)
- New brain metastases during follow-up after previous SRT allowed (when outside of previous irradiation field)
Who cannot join
- Contra-indication for MRI scan
- Primary tumor of small cell lung cancer, germinoma or lymphoma
- Prior whole brain radiotherapy or SRT on the current target brain metastases (in field re-irradiation)
- Presence of leptomeningeal metastases
- Previous inclusion in the SAFESTEREO study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands1 site, 1 recruiting
- Recruiting
Haaglanden Medisch Centrum
Leidschendam, South Holland, 2262 BA
Jaap Zindler, Dr, j.zindler@haaglandenmc.nl
Ursula Fisscher, PhD, u.fisscher@haaglandenmc.nl
About this study
Randomized phase II trial. The study aims to investigate a different and potentially safer radio therapeutic treatment method for brain metastases. The current standard of stereotactic radiotherapy (SRT) in one or three fractions is compared to fractionated stereotactic radiotherapy (fSRT) in five fractions.
Read the detailed description
Randomized phase II trial. Stereotactic radiotherapy is one of the most frequently chosen treatment options for brain metastases. There are an increasing number of long term survivors. Brain necrosis (e.g. radio necrosis) is the most important long term side effect of the treatment, occurring in up to 40% of patients, dependent on the size of the metastasis and delivered radiotherapy dose. Retrospective studies have shown that the incidence of radio necrosis, as well as local tumor recurrence, can be decreased with a risk difference of around 20% by administrating fractionated stereotactic radiotherapy (fSRT, e.g. five fractions) over single fraction stereotactic radiotherapy, especially in large brain metastases. In this trial, one group is treated with SRT in one or three fractions. The other group is treated with fSRT in five fractions. Survival, toxicity and patient reported quality of life are monitored.
- Conditions
- Brain Metastases
- Being tested
- SRT, fSRT
- Keywords
- fractionated stereotactic radiotherapy
- Medical subject headings
- Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SRTRadiation
SRT
fSRTRadiation
fSRT
| Study group | Role | What they receive |
|---|---|---|
| SRT (stereotactic radiotherapy) | Active comparator | stereotactic radiotherapy in 1 or 3 fractions of 8 Gy up to 15-24 Gy Receives: Radiation: SRT |
| fSRT (hypo fractionated stereotactic radiotherapy) | Experimental | hypo fractionated stereotactic radiotherapy in 5 fractions of 7 Gy up to 35 Gy. Brain stem metastases 5 fractions of 6 Gy up to 30 Gy Receives: Radiation: fSRT |
What is being measured
The primary outcome is the main question the study is designed to answer.
radio necrosis or local failure
Incidence of either radio necrosis or local failure according to Response Assessment in Neuro-Oncology Brain Metastases (RANO-BM).
Measured: 2 years after treatment
Secondary outcomes (7)
Survival
median survival with Kaplan Meyer analysis
Measured: 2 years after treatment
symptomatic radio necrosis (RN) or local failure (LF)
incidence of RN or LF within 2 years after SRT
Measured: 2 years after treatment
salvage treatment
incidence of salvage treatment within 2 years after SRT
Measured: 2 years after treatment
distant brain recurrences
incidence of distant brain recurrences within 2 years after SRT
Measured: 2 years after treatment
Dose dexamethasone
Dose dexamethasone in mg per day
Measured: baseline - 2 years after treatment
Anti-epileptic drug use
Anti-epileptic drug use in mg per day
Measured: baseline - 2 years after treatment
Grade 2 or more toxicity (CTCAE v5.0)
incidence of Grade 2 or more toxicity according to CTCAE version 5.0 within 2 years after SRT
Measured: baseline - 2 years after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2022
- Study start18 Jul 2022
- Primary completionMar 2027 (estimated)
- Study completionMar 2027 (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 Brain MetastasesStudies of the same condition, open and under way.
- 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
- Model description
- 1:1 randomization
- Masking
- None (open label)
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Haaglanden Medical Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jaap Zindler, Haaglanden Medical Centre
- Investigators
- Jaap D Zindler, MD, PhD, Principal investigator, Haaglanden MC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05346367
- Sponsor's protocol ID
- 2021-115LR
- Acronym
- SAFESTEREO
- Status last verified
- Mar 2024
- First submitted
- 13 Apr 2022
- Last updated
- 12 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Crouzen JA, Petoukhova AL, Broekman MLD, Fiocco M, Fisscher UJ, Franssen JH, Gadellaa-van Hooijdonk CGM, Kerkhof M, Kiderlen M, Mast ME, van Rij CM, Nandoe Tewarie R, van de Sande MAE, van der Toorn PPG, Vlasman R, Vos MJ, van der Voort van Zyp NCMG, Wiggenraad RGJ, Wiltink LM, Zindler JD. SAFESTEREO: phase II randomized trial to compare stereotactic radiosurgery with fractionated stereotactic radiosurgery for brain metastases. BMC Cancer. 2023 Mar 25;23(1):273. doi: 10.1186/s12885-023-10761-1.
PubMed 36964529
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Therapeutic Ratio With Hypo Fractionated Stereotactic Radiotherapy for Brain Metastases
- ClinicalTrials.gov ID
- NCT05346367
- Acronym / sponsor ID
- SAFESTEREO / 2021-115LR
- Conditions
- Brain Metastases
- Keywords
- fractionated stereotactic radiotherapy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- Haaglanden Medical CentreUniversity, hospital or other
- Study start
- 18 Jul 2022 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 26 Apr 2022 (actual)
- 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.
Randomized phase II trial. The study aims to investigate a different and potentially safer radio therapeutic treatment method for brain metastases. The current standard of stereotactic radiotherapy (SRT) in one or three fractions is compared to fractionated stereotactic radiotherapy (fSRT) in five fractions.
Detailed description
Randomized phase II trial. Stereotactic radiotherapy is one of the most frequently chosen treatment options for brain metastases. There are an increasing number of long term survivors. Brain necrosis (e.g. radio necrosis) is the most important long term side effect of the treatment, occurring in up to 40% of patients, dependent on the size of the metastasis and delivered radiotherapy dose. Retrospective studies have shown that the incidence of radio necrosis, as well as local tumor recurrence, can be decreased with a risk difference of around 20% by administrating fractionated stereotactic radiotherapy (fSRT, e.g. five fractions) over single fraction stereotactic radiotherapy, especially in large brain metastases. In this trial, one group is treated with SRT in one or three fractions. The other group is treated with fSRT in five fractions. Survival, toxicity and patient reported quality of life are monitored.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 1:1 randomization
| Arm | Type | Receives |
|---|---|---|
| SRT (stereotactic radiotherapy) | Active comparator | Radiation: SRTstereotactic radiotherapy in 1 or 3 fractions of 8 Gy up to 15-24 Gy |
| fSRT (hypo fractionated stereotactic radiotherapy) | Experimental | Radiation: fSRThypo fractionated stereotactic radiotherapy in 5 fractions of 7 Gy up to 35 Gy. Brain stem metastases 5 fractions of 6 Gy up to 30 Gy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age ≥ 18 years
- At least one brain metastasis of large cell cancer suitable for SRT
- Karnofsky Performance Status ≥ 70
- Ability to provide written informed consent
- New brain metastases during follow-up after surgery allowed (when outside of resection cavity area)
Key exclusion criteria (5 listed)
- Contra-indication for MRI scan
- Primary tumor of small cell lung cancer, germinoma or lymphoma
- Prior whole brain radiotherapy or SRT on the current target brain metastases (in field re-irradiation)
- Presence of leptomeningeal metastases
- Previous inclusion in the SAFESTEREO study
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 |
|---|---|---|
| SRTSRT | Radiation | SRT (stereotactic radiotherapy) |
| fSRTfSRT | Radiation | fSRT (hypo fractionated stereotactic radiotherapy) |
Primary outcome
radio necrosis or local failure
Time frame: 2 years after treatment
Incidence of either radio necrosis or local failure according to Response Assessment in Neuro-Oncology Brain Metastases (RANO-BM).
7 secondary outcomes
Survival
Time frame: 2 years after treatment
symptomatic radio necrosis (RN) or local failure (LF)
Time frame: 2 years after treatment
salvage treatment
Time frame: 2 years after treatment
distant brain recurrences
Time frame: 2 years after treatment
Dose dexamethasone
Time frame: baseline - 2 years after treatment
Anti-epileptic drug use
Time frame: baseline - 2 years after treatment
Grade 2 or more toxicity (CTCAE v5.0)
Time frame: baseline - 2 years after treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2024.
- Derived from this study: PubMed 36964529Crouzen JA, Petoukhova AL, Broekman MLD, Fiocco M, Fisscher UJ, Franssen JH, Gadellaa-van Hooijdonk CGM, Kerkhof M, Kiderlen M, Mast ME, van Rij CM, Nandoe Tewarie R, van de Sande MAE, van der Toorn PPG, Vlasman R, Vos MJ, van der Voort van Zyp NCMG, Wiggenraad RGJ, Wiltink LM, Zindler JD. SAFESTEREO: phase II randomized trial to compare stereotactic radiosurgery with fractionated stereotactic radiosurgery for brain metastases. BMC Cancer. 2023 Mar 25;23(1):273. doi: 10.1186/s12885-023-10761-1.
- 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.
Jaap D Zindler, MD, PhD principal investigator
Haaglanden MC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SRT and fSRT in people with Brain Metastases, run by Haaglanden Medical Centre at 1 site 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 5 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: looking for participants now, as of the sponsor's last update on 12 Mar 2024. 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 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jaap D Zindler, MD, PhD (+31-88-9792013, j.zindler@haaglandenmc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
radio necrosis or local failure (time frame: 2 years after treatment). 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 NCT05346367, 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 12 Mar 2024.