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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05346367
Other study ID # 2021-115LR
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date July 18, 2022
Est. completion date March 2027

Study information

Verified date March 2024
Source Haaglanden Medical Centre
Contact Jaap D Zindler, MD, PhD
Phone +31-88-9792013
Email j.zindler@haaglandenmc.nl
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 130
Est. completion date March 2027
Est. primary completion date March 2027
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - 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) Exclusion Criteria: - 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

Study Design


Related Conditions & MeSH terms


Intervention

Radiation:
SRT
SRT
fSRT
fSRT

Locations

Country Name City State
Netherlands Haaglanden Medisch Centrum Leidschendam Zuid-Holland

Sponsors (1)

Lead Sponsor Collaborator
Haaglanden Medical Centre

Country where clinical trial is conducted

Netherlands, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Survival median survival with Kaplan Meyer analysis 2 years after treatment
Secondary symptomatic radio necrosis (RN) or local failure (LF) incidence of RN or LF within 2 years after SRT 2 years after treatment
Secondary salvage treatment incidence of salvage treatment within 2 years after SRT 2 years after treatment
Secondary distant brain recurrences incidence of distant brain recurrences within 2 years after SRT 2 years after treatment
Secondary Dose dexamethasone Dose dexamethasone in mg per day baseline - 2 years after treatment
Secondary Anti-epileptic drug use Anti-epileptic drug use in mg per day baseline - 2 years after treatment
Secondary 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 baseline - 2 years after treatment
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