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

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

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON43850

Enrollment

Registered

2015-04-15

Start date

2015-09-21

Completion date

Unknown

Last updated

2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

brain metastasis tumor in the brain

Interventions

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).

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

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 outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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.	—

Measure

Time frame

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.

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)