Trial of Preoperative Radiosurgery Versus Postoperative Stereotactic Radiotherapy for Resectable Brain Metastases

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorSusanne Rogers

About this trial

The research question is whether a single fraction of preoperative radiosurgery can reduce the incidence of leptomeningeal disease 12 months following resection of a brain metastasis (BM) as compared with 5 fractions of postoperative stereotactic radiotherapy.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Provision of signed and dated informed consent form

Stated willingness to comply with all study procedures and availability for the duration of the study

Age ≥18

Karnofsky performance status ≥60

Disqualifiers

Radiosensitive histology: germ cell tumour, lymphoma, multiple myeloma

>10 mm midline shift, effacement of the 4th ventricle or other sign of raised intracranial pressure requiring urgent decompressive surgery

More than 4 brain metastases or the diameter of the metastasis for resection >4.0 cm.

More than 1 metastasis requiring resection

Trial design

Design model

Parallel

Treatments tested in this trial

  • preoperative radiosurgery

    Radiation

    single fraction radiosurgery

  • postoperative hypofractionated stereotactic radiotherapy

    Radiation

    fractionated stereotactic radiotherapy /radiosurgery in 1 to 6 fractions according to local standard of care

Treatment groups

200 Participants
are divided into 2 treatment groups
Group A: Preoperative radiosurgeryExperimental treatment 1 intervention
Group B: Postoperative hypofractionated stereotactic radiotherapyActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Leptomeningeal disease

time to leptomeningeal disease

Time frame
12 months after intervention

Secondary outcomes

1

Local control of the surgical cavity

No evidence of tumour recurrence on contrast-enhanced MRI

Time frame
12 months after intervention
2

Distant brain failure

New brain metastases

Time frame
12 months after intervention
3

Radionecrosis

Adverse radiation effects

Time frame
12 months after intervention
4

Quality of life assessment

EORTC questionnaire core questionnaire QLQ30, EORTC questionnaire brain module BN 20 (1-4, low scores reflect better QoL)

Time frame
3,6,12 months after intervention

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Susanne Rogers

Lead sponsor

Kantonsspital Aarau

Sponsor institution

University of Basel

Collaborator