Improving Therapeutic Ratio With Hypo Fractionated Stereotactic Radiotherapy for Brain Metastases

Brain Metastases Clinical Trial

— SAFESTEREO  

Official title:

Improving Therapeutic Ratio With Hypo Fractionated Stereotactic Radiotherapy for Brain Metastases

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05346367
• Other study ID #: 2021-115LR
• Status: Recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Brain Metastases
• Brain Neoplasms
• Neoplasm Metastasis

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