Skip to main content

Table 1 Selection criteria

From: Preoperative stereotactic radiosurgery for brain metastases: the STEP study protocol for a multicentre, prospective, phase-II trial

Inclusion criteria

Non-inclusion criteria

≤ 4 distinct brain metastases, one with surgical indication

Lymphoma, leukaemia, multiple myeloma, germinal tumours or cerebral primary cancer

Diagnosis of histologically proven breast, digestive, non-small cells lung cancer, kidney or melanoma

Metastases from small-cells lung cancer or sarcoma

≤ 5 cm larger diameter

Mass effect with deflection ≥5 mm from median line or hydrocephaly or compression 4th ventricle, patient neurologically unstable, need for emergency decompressive surgery

Karnofsky performance status ≥70

>  4 brain metastases

No contraindication for MRI

Contraindication to anaesthesia, MRI or gadolinium injection

Possibility for the patient to be treat with both surgery and stereotactic radiotherapy

Proximity of the tumour with organs at risk which do not allow the prescribed dose to be reached in the envelope

≥ 18 years old

Pregnant or breastfeeding woman

Estimated overall survival ≥6 months according to DS GPA

Anti VEGF within 6 weeks before treatment

Written inform consent signed

Documented leptomeningeal injury

Affiliation to the French social security system

History of irradiation of the encephalon in toto

For women of childbearing age including those on LH-RH agonists for ovarian suppression: inclusion negative serum pregnancy test (≤ 7 days prior to the start of preoperative RSH).

History of stereotactic radiotherapy on metastasis to be operated on

 

Non-candidate patient for surgery

 

Surgical delay > 3 days compared to stereotactic radiotherapy

 

Estimated survival < 6 months by DS GPA

 

Patient under guardianship or curatorship

 

Psychological disorder (cognitive disorders, mental alertness, etc.) or social (deprivation of liberty by judicial or administrative decision) or geographical reasons that may compromise medical monitoring of the trial or compliance with treatment

 

Woman of childbearing age without effective contraception

 

Patient participating in another intervention study within 4 weeks prior to inclusion