To determine if the incidence of adverse local events (local failure or radionecrosis) can be reduced with more than 20% using fSRT versus SRT in one or three fractions.
ID
Source
Brief title
Condition
- Metastases
- Nervous system, skull and spine therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameter is the incidence of adverse local event (either
radionecrosis or local failure according to RANO) at 2 year post-radiotherapy
with respect to baseline
Secondary outcome
- Survival
- Quality of life
- Seizure outcome
- Toxicity
Background summary
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. radionecrosis) 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 radionecrosis, 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.
Study objective
To determine if the incidence of adverse local events (local failure or
radionecrosis) can be reduced with more than 20% using fSRT versus SRT in one
or three fractions.
Study design
Prospective cohort study with two cohorts. Randomized study with two
randomization arms. Patients are randomly placed in one of the two groups .
Intervention
One group is treated with SRT in one or three fractions. The other group is
treated with fSRT in five fractions.
Study burden and risks
The study aims to investigate a different and potentially safer treatment
method than the current standard of care. It is unlikely that the risk of
adverse events will be increased in the experimental cohort compared to the
standard cohort. The additional burden as a result of study participation
consists of the following: between two and four additional site visits for
treatment in the experimental group; a total of eighteen (facultative)
questionnaires spread throughout the follow-up period.
Burgemeester Banninglaan 1
Leidschendam 2262BA
NL
Burgemeester Banninglaan 1
Leidschendam 2262BA
NL
Listed location countries
Age
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
- Previous systemic therapy for brain metastases allowed
- New brain metastases during follow-up after surgery allowed (outside
resection cavity)
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
(BM) (in field re-irradiation; salvage SRT of non-irradiated BM allowed if
radiation dose from previous irradiation in current target field is <1.0 Gy)
- The presence of leptomeningeal metastases
- Previous inclusion in the SAFESTEREO study
-Active bleeding metastases
Design
Recruitment
Medical products/devices used
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | NCT05346367 |
| CCMO | NL77876.058.21 |