Improving Therapeutic Ratio With Hypo Fractionated Stereotactic Radiotherapy for Brain Metastases

Not Applicable

Recruiting

• Conditions: Brain Metastases

• Registration Number: NCT05346367
• Lead Sponsor: Haaglanden Medical Centre

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.

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 Timeline

• Study First Submitted: 2022-04-13
• Study First Submitted QC: 2022-04-20
• Study First Posted: 2022-04-26
• Study Start: 2022-07-18
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-06
• Last Update Posted: 2024-03-12
• Primary Completion: 2027-03
• Study Completion: 2027-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 130

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
radio necrosis or local failure	2 years after treatment	Incidence of either radio necrosis or local failure according to Response Assessment in Neuro-Oncology Brain Metastases (RANO-BM).

Secondary Outcome Measures

Name	Time	Method
distant brain recurrences	2 years after treatment	incidence of distant brain recurrences within 2 years after SRT
symptomatic radio necrosis (RN) or local failure (LF)	2 years after treatment	incidence of RN or LF within 2 years after SRT
Survival	2 years after treatment	median survival with Kaplan Meyer analysis
salvage treatment	2 years after treatment	incidence of salvage treatment within 2 years after SRT
Dose dexamethasone	baseline - 2 years after treatment	Dose dexamethasone in mg per day
Anti-epileptic drug use	baseline - 2 years after treatment	Anti-epileptic drug use in mg per day
Grade 2 or more toxicity (CTCAE v5.0)	baseline - 2 years after treatment	incidence of Grade 2 or more toxicity according to CTCAE version 5.0 within 2 years after SRT

Trial Locations

Locations (1)

Haaglanden Medisch Centrum; 🇳🇱 Leidschendam, Zuid-Holland, Netherlands