Improving Therapeutic Ratio With Hypo Fractionated Stereotactic Radiotherapy for Brain Metastases
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 130
- Locations
- 2
- Primary Endpoint
- radio necrosis or local failure
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
SRT (stereotactic radiotherapy)
stereotactic radiotherapy in 1 or 3 fractions of 8 Gy up to 15-24 Gy
Intervention: SRT (Radiation)
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
Intervention: fSRT (Radiation)
Outcomes
Primary Outcomes
radio necrosis or local failure
Time Frame: 2 years after treatment
Incidence of either radio necrosis or local failure according to Response Assessment in Neuro-Oncology Brain Metastases (RANO-BM).
Secondary Outcomes
- symptomatic radio necrosis (RN) or local failure (LF)(2 years after treatment)
- distant brain recurrences(2 years after treatment)
- Survival(2 years after treatment)
- salvage treatment(2 years after treatment)
- Dose dexamethasone(baseline - 2 years after treatment)
- Anti-epileptic drug use(baseline - 2 years after treatment)
- Grade 2 or more toxicity (CTCAE v5.0)(baseline - 2 years after treatment)
Investigators
Jaap Zindler
Principal Investigator, MD, PhD, radiation oncologist
Haaglanden Medical Centre