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

Maastricht Radiation Oncology

Status: Terminated

Conditions: Neoplasm Metastasis

Treatments: Radiation: Whole Brain Radiotherapy; Radiation: Stereotactic Radiosurgery

Study type: Interventional

Funder types: Other

Identifiers

NCT02353000

01-2015

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 31 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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31 participants in 2 patient groups

Stereotactic Radiosurgery

Experimental group

Description:

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

Treatment:

Radiation: Stereotactic Radiosurgery

Whole Brain Radiotherapy

Other group

Description:

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

Treatment:

Radiation: Whole Brain Radiotherapy