Postoperative local stereotactic radiotherapy versus observation following complete resection of a single brain metastasis

Phase 3

Completed

Conditions: brain metastasis
tumor in the brain
10027476

Registration Number: NL-OMON43850

Lead Sponsor: Vrije Universiteit Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 70

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary endpoint of this study is local control at the resection site at<br /><br>six months from the date of surgery, defined as the absence of nodular<br /><br>contrast-enhancing lesion(s) at the resection site on follow-up MRI scans,<br /><br>suspected for tumor recurrence and not radiation necrosis.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The secondary endpoints of this study are local control at 12 months, overall<br /><br>survival, and freedom from clinical-neurological progression. Other secondary<br /><br>endpoints are treatment-related toxicity, including radiation-induced necrosis,<br /><br>WHO performance score, steroid use, neurocognitive functioning and quality of<br /><br>life. The incidence of new lesions outside of the treated volume will be<br /><br>documented in both arms.</p><br>