Improving Therapeutic Ratio With Hypo Fractionated Stereotactic Radiotherapy for Brain Metastases
NCT ID: NCT05346367
Last Updated: 2024-03-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
130 participants
INTERVENTIONAL
2022-07-18
2027-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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SRT (stereotactic radiotherapy)
stereotactic radiotherapy in 1 or 3 fractions of 8 Gy up to 15-24 Gy
SRT
SRT
fSRT (hypo fractionated stereotactic radiotherapy)
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
fSRT
fSRT
Interventions
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SRT
SRT
fSRT
fSRT
Eligibility Criteria
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Inclusion Criteria
* 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)
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Haaglanden Medical Centre
OTHER
Responsible Party
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Jaap Zindler
Principal Investigator, MD, PhD, radiation oncologist
Principal Investigators
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Jaap D Zindler, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Haaglanden MC
Locations
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Haaglanden Medisch Centrum
Leidschendam, South Holland, Netherlands
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Provided Documents
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Document Type: Study Protocol
Other Identifiers
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2021-115LR
Identifier Type: -
Identifier Source: org_study_id
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