To improve local control following complete resection of a single brain metastasis using fractionated local stereotactic radiotherapy, whilst maintaining neurological functioning, neurocognition and quality of life.
ID
Source
Brief title
Condition
- Metastases
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary endpoint of this study is local control at the resection site at
six months from the date of surgery, defined as the absence of nodular
contrast-enhancing lesion(s) at the resection site on follow-up MRI scans,
suspected for tumor recurrence and not radiation necrosis.
Secondary outcome
The secondary endpoints of this study are local control at 12 months, overall
survival, and freedom from clinical-neurological progression. Other secondary
endpoints are treatment-related toxicity, including radiation-induced necrosis,
WHO performance score, steroid use, neurocognitive functioning and quality of
life. The incidence of new lesions outside of the treated volume will be
documented in both arms.
Background summary
A randomized EORTC trial published in 2011 showed equivalence in overall- and
independent survival between groups treated with postoperative whole brain
radiotherapy (WBRT) versus observation following complete resection of a single
brain metastasis [Kocher 2011]. A subsequent analysis of health-related quality
of life observed an inferior outcome after WBRT, although mostly transient
[Sofietti 2013]. Local stereotactic radiotherapy of the surgical cavity can be
a good alternative to both observation and to whole brain radiotherapy,
However, this has not been investigated in a randomized way. The current study
aims to compare the outcome of local radiotherapy on the surgical cavity versus
observation after complete resection in patients with a single brain metastasis
of a solid tumor, in terms of local control, neurological functioning,
neurocognition and quality of life.
Study objective
To improve local control following complete resection of a single brain
metastasis using fractionated local stereotactic radiotherapy, whilst
maintaining neurological functioning, neurocognition and quality of life.
Study design
Multicenter randomized phase III, with at least three high-volume Dutch centers
participating in the trial. Stratification on primary tumor type and age.
Intervention
Patients will be randomized between observation alone (standard arm) and local
stereotactic radiotherapy in three fractions of 8 Gy to the surgical cavity
(study arm).
Study burden and risks
The burden for the patient associated with participation in the study is mainly
due to three-montly filling in Quality of Life questionaires and a shortened
neurocognitive testing at baseline, at 3, 6 and 12 months.
The risk of potential toxicity in the experimental (stereotactic radiotherapy)
arm is estimated to be 5-10%, mainly in the form of fatigue and local hair
loss. Occasionally, during radiation treatment-induced local swelling is
observed, for which temporarily steroids have to be prescribed. Long-term side
effects, i.e. radiation-induced necrosis, is anticipated to be observed in less
than 5% of patients, of which symptomatic in half of these patients. If
symptomatic, patients could be treated with steroids, or occasionally, surgery.
De Boelelaan 1118
Amsterdam 1007 MB
NL
De Boelelaan 1118
Amsterdam 1007 MB
NL
Listed location countries
Age
Inclusion criteria
- Age of 18 years or older.
- Radiologically confirmed complete resection of a single brain metastasis on a
contrast-enhanced MRI within 72 h after resection.
- Primary solid tumor, excluding hematologic malignancy, germ cell tumor, small cell
lung cancer.
- Stable extracranial tumor (primary tumor and/or systemic metastases) during the
last three months with or without treatment or progressive extracranial tumor and/or
systemic metastases for which effective treatment is available.
- WHO performance score 0-2.
- Ability to provide written informed consent.
Exclusion criteria
- Prior treatment for brain metastases (i.e. surgery, stereotactic radiotherapy or WBRT).
- Distant brain metastases or radiological findings on MRI suspected for
leptomeningeal tumor spread on the treatment planning MRI.
- Concurrent use of systemic therapy during local stereotactic radiotherapy
Design
Recruitment
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 |
|---|---|
| CCMO | NL51283.029.14 |