Whole Brain Radiotherapy (WBRT) Versus Stereotactic Radiosurgery (SRS) for 4 Upto 10 Brain Metastases

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

31 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-07-31

Study Completion Date

2019-12-31

Brief Summary

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Recently stereotactic radiosurgery (SRS) in 5 up to 10 brain metastases showed to have equal survival as in 2 up to 4 brain metastases. Whole brain radiotherapy (WBRT) is currently the gold standard for patients with more than 3 brain metastases, but has significant side effects. In this prospective randomized phase III trial WBRT is compared to SRS for patients with 4 up to 10 BM.

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Detailed Description

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Dutch guideline advices stereotactic radiosurgery (SRS) for patients with 1 up to 3 brain metastases (BM) and whole brain radiotherapy (WBRT) for patients with 4 or more BM. The interim analysis from the QUARTZ study showed that WBRT did not provide benefit in quality of life nor survival over best supportive care. WBRT has significant side effects, such as hair loss, fatigue, and cognitive dysfunction which may impair quality of life. A recently published study showed that SRS in patients with 5 up to 10 BM had a comparable survival to patients treated with 2 up to 4 BM. Many systemic therapies do not have a satisfactory intracranial response, because of the blood-brain barrier. The potential advantages of SRS i.e, limiting radiation doses to the uninvolved brain and a high rate of local tumour control by just a single treatment. Next logic step would be to compare WBRT with SRS alone in patients with 4-10 BM and evaluate whether SRS is superior to WBRT with regard to QOL.

Conditions

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Neoplasm Metastasis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Stereotactic Radiosurgery

Stereotactic Radiosurgery for patients with 4 up to 10 brain metastases:

Group Type EXPERIMENTAL

Stereotactic Radiosurgery

Intervention Type RADIATION

Stereotactic Radiosurgery for patients with 4 up to 10 brain metastases

Whole Brain Radiotherapy

Whole Brain Radiotherapy for patients with 4 up to 10 brain metastases:

Group Type OTHER

Whole Brain Radiotherapy

Intervention Type RADIATION

Whole Brain Radiotherapy for patients with 4 up to 10 brain metastases

Interventions

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Stereotactic Radiosurgery

Stereotactic Radiosurgery for patients with 4 up to 10 brain metastases

Intervention Type RADIATION

Whole Brain Radiotherapy

Whole Brain Radiotherapy for patients with 4 up to 10 brain metastases

Intervention Type RADIATION

Eligibility Criteria

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Inclusion Criteria

* Minimal 4 up to a maximum of 10 BM on diagnostic MRI scan
* Max diameter of single GTV 2.5cm
* Max cumulative GTV of 30cm3
* Karnofsky performance status ≥ 70
* Any solid primary tumour. Small cell lung carcinoma, germinoma, and lymphoma are excluded
* Ability to provide written informed consent

Exclusion Criteria

* Contra-indication for MRI
* Prior treatment for BM (i.e. surgery, SRS or WBRT)
* Concurrent use of systemic therapy
* Maximum cumulative GTV of more than 30cm3 on planning-MRI
* More than 10 BM on planning-MRI
* A brainstem metastasis with a PTV of more than 20 cm3

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No