Local Radiotherapy Following Complete Resection of a Brain Metastasis

NCT ID: NCT02729558

Last Updated: 2019-05-20

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-05-31
• Study Completion Date: 2017-05-31

Brief Summary

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.

Study population: Patients undergoing complete resection of a single brain metastasis, confirmed by an early (i.e. within 72 hours) postoperative contrast-enhanced MR scan.

Study 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).

Main study parameters: Primary objective: local control rate at 6 months. Secondary objectives: local control rate at 12 months, neurological functioning, freedom from clinical neurological progression, performance status, quality of life, toxicity, steroid use, neurocognition and overall survival.

Detailed Description

The objective of this study is to improve local control following complete resection of a single brain metastasis of solid tumors using fractionated local stereotactic radiotherapy, whilst maintaining neurological functioning, neurocognition and quality of life. The study is performed in the form of a multicenter randomized phase III, with at least three high-volume Dutch centers participating in the trial. Stratification will be performed on primary tumor type and age. A total of 70 patients will be included. Inclusion is restricted to patients who underwent a complete resection of a single brain metastasis, confirmed by an early (i.e. within 72 hours) postoperative contrast-enhanced magnetic resonance (MR) scan. 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).The main study parameters are: local control rate at 6 months (primary outcome measure) and local control rate at 12 months, neurological functioning, freedom from clinical neurological progression, performance status, quality of life, toxicity, steroid use, neurocognition and overall survival (secondary outcome measures). Follow up will be performed at three-monthly interval during the first two years, including MRI scans. Quality of life questionaires and neurocognitive functioning tests will be performed at fixed intervals during follow-up.

Conditions

Brain Neoplasms

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

observation

Watchful waiting

Group Type: NO_INTERVENTION

No interventions assigned to this group

local stereotactic radiotherapy (SRT)

local SRT in three fractions of 8 Gy to the surgical cavity

Group Type: ACTIVE_COMPARATOR

local SRT

Intervention Type: RADIATION

local stereotactic radiotherapy in three fractions of 8 Gy to the surgical cavity

Interventions

local SRT

local stereotactic radiotherapy in three fractions of 8 Gy to the surgical cavity

Intervention Type: RADIATION

Other Intervention Names

stereotactic radiotherapy; radiosurgery

Eligibility 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.
• World Health Organization (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 postoperative MRI.
• Concurrent use of systemic therapy during local stereotactic radiotherapy

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Netherlands Cancer Institute

OTHER

Sponsor Role: collaborator

UMC Utrecht

OTHER

Sponsor Role: collaborator

Amsterdam UMC, location VUmc

OTHER

Sponsor Role: lead

Responsible Party

Anna Bruynzeel

MD PhD Radiation Oncologist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Netherlands Cancer Institute - Antoni van Leeuwenhoek

Amsterdam, , Netherlands

VU University medical center

Amsterdam, , Netherlands

Countries

Netherlands

Other Identifiers

NL5128302914

Identifier Type: -

Identifier Source: org_study_id