NCT05346367

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
130

participants targeted

Target at P50-P75 for not_applicable

Timeline
10mo left

Started Jul 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress82%
Jul 2022Mar 2027

First Submitted

Initial submission to the registry

April 13, 2022

Completed
13 days until next milestone

First Posted

Study publicly available on registry

April 26, 2022

Completed
3 months until next milestone

Study Start

First participant enrolled

July 18, 2022

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2027

Last Updated

March 12, 2024

Status Verified

March 1, 2024

Enrollment Period

4.6 years

First QC Date

April 13, 2022

Last Update Submit

March 6, 2024

Conditions

Brain Metastases

Keywords

fractionated stereotactic radiotherapy

Outcome Measures

Primary Outcomes (1)

  • radio necrosis or local failure

    Incidence of either radio necrosis or local failure according to Response Assessment in Neuro-Oncology Brain Metastases (RANO-BM).

    2 years after treatment

Secondary Outcomes (7)

  • Survival

    2 years after treatment

  • symptomatic radio necrosis (RN) or local failure (LF)

    2 years after treatment

  • salvage treatment

    2 years after treatment

  • distant brain recurrences

    2 years after treatment

  • Dose dexamethasone

    baseline - 2 years after treatment

  • +2 more secondary outcomes

Study Arms (2)

SRT (stereotactic radiotherapy)

ACTIVE COMPARATOR

stereotactic radiotherapy in 1 or 3 fractions of 8 Gy up to 15-24 Gy

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

Radiation: fSRT

Interventions

SRTRADIATION

SRT

SRT (stereotactic radiotherapy)
fSRTRADIATION

fSRT

fSRT (hypo fractionated stereotactic radiotherapy)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Haaglanden Medisch Centrum

Leidschendam, South Holland, 2262 BA, Netherlands

RECRUITING

Related Publications (1)

  • 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.

    PMID: 36964529DERIVED

MeSH Terms

Conditions

Brain Neoplasms

Condition Hierarchy (Ancestors)

Central Nervous System NeoplasmsNervous System NeoplasmsNeoplasms by SiteNeoplasmsBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Jaap D Zindler, MD, PhD

    Haaglanden MC

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jaap D Zindler, MD, PhD

CONTACT

+31-88-9792013j.zindler@haaglandenmc.nl

Mirjam Mast, PhD

CONTACT

+31-88-9792013m.mast@haaglandenmc.nl

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 1:1 randomization
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator, MD, PhD, radiation oncologist

Study Record Dates

First Submitted

April 13, 2022

First Posted

April 26, 2022

Study Start

July 18, 2022

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

March 1, 2027

Last Updated

March 12, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

Locations

NL(1)