Clinical trial NCT05346367: Improving Therapeutic Ratio With Hypo Fractionated Stereotactic Radiotherapy for Brain Metastases
Official title: Improving Therapeutic Ratio With Hypo Fractionated Stereotactic Radiotherapy for Brain Metastases
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Brain Metastases
Keywords: fractionated stereotactic radiotherapy
Lead sponsor: Haaglanden Medical Centre
Sponsor class: OTHER
First posted: 2022-04-26
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 1:1 randomization
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: radio necrosis or local failure
timeFrame: 2 years after treatment
Secondary outcomes:
measure: Survival
timeFrame: 2 years after treatment
measure: symptomatic radio necrosis (RN) or local failure (LF)
timeFrame: 2 years after treatment
measure: salvage treatment
timeFrame: 2 years after treatment
measure: distant brain recurrences
timeFrame: 2 years after treatment
measure: Dose dexamethasone
timeFrame: baseline - 2 years after treatment
measure: Anti-epileptic drug use
timeFrame: baseline - 2 years after treatment
measure: Grade 2 or more toxicity (CTCAE v5.0)
timeFrame: baseline - 2 years after treatment
Other outcomes:
Locations:
city: Leidschendam
country: Netherlands
facility: Haaglanden Medisch Centrum
state: Zuid-Holland
Study officials:
affiliation: Haaglanden MC
name: Jaap D Zindler, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: