Skip to main content
OpenTrials
Completed

NCT Number: NCT04503772

Preoperative Stereotactic Radiosurgery for Brain Metastases

STEP is a French multicentre, prospective, non-randomized, phase II study designed to assess 6-months local control after pre-operative stereotactic radiosurgery (SRS) for patients with brain metastases

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Brain Metastases Brain Diseases Brain Neoplasms Central Nervous System Diseases Central Nervous System Neoplasms Neoplasms Neoplasms by Site Nervous System Diseases Nervous System Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Centre Jean PERRIN, Clermont-Ferrand, Puy-de-Dôme, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • ≤ 4 distinct brain metastases, one with surgical indication
  • Diagnosis of primary histologically proven breast, digestive or non-small cells lung cancer
  • ≤ 5 cm larger diameter
  • Karnofsky performance status ≥ 70
  • No contraindication for MRI
  • Possibility for the patient to be treat with both surgery and stereotactic radiotherapy
  • ≥ 18 years old
  • Estimated overall survival ≥ 6 months according to diagnosis specific - graded prognostic assessment (DS GPA)
  • Written inform consent signed
  • Affiliation to the French social security system
  • For women of childbearing age including those on luteinizing hormone-releasing hormone (LH-RH) agonists for ovarian suppression: inclusion negative serum pregnancy test (≤ 7 days prior to the start of preoperative stereotactic radiosurgery (SRS).

Exclusion criteria

  • Lymphoma, leukaemia, multiple myeloma, germinal tumours or cerebral primary cancer
  • Metastases from small-cells lung cancer, kidney cancer, melanoma or sarcoma
  • Mass effect with deflection ≥ 5 mm from median line or hydrocephaly or compression 4th ventricle, patient neurologically unstable, need for emergency decompressive surgery
  • > 4 brain metastases
  • Contraindication to anaesthesia, MRI or gadolinium injection
  • Proximity of the tumour with organs at risk which do not allow the prescribed dose to be reached in the envelope
  • Pregnant or breastfeeding woman
  • Anti vascular endothelial growth factor (VEGF) within 6 weeks before treatment
  • Documented leptomeningeal injury
  • History of irradiation of the encephalon in toto
  • 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 curators
  • 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

Treatment and study plan

Preoperative SRS

Procedure

Patient will be treat with preoperative SRS and then surgery for brain metastases is realized within 3 days.

Primary outcomes

  1. Evaluation of 6-months local control rate after preoperative SRS

    Time frame: 6 months after preoperative SRS (M6)

    Local recurrence is defined as the onset or progression of nodular contrast grafting within the resection cavity according to the Response Assessment in Neuro-Oncology Brain Metastases (RANO-BM) criteria.

Secondary outcomes

  1. Evaluation of 1-year local control rate after preoperative SRS

    Time frame: 12 months after preoperative SRS (M12)

    Local recurrence is defined as the onset or progression of nodular contrast grafting within the resection cavity according to the RANO-BM criteria.

  2. Evaluation of 1-year radionecrosis rate after preoperative SRS

    Time frame: 12 months after preoperative SRS (M12)

    Radionecrosis is defined either histologically post-operatively according to the anatomopathological report or in the absence of salvage surgery by the appearance or increase of gadolinium contrast on T1 MRI sequences associated with an increase in the cerebral brain volume (CBV) ratio (brain blood volume of the tumour / brain blood volume of the non-tumour white matter) of less than 2 on perfusion MRI sequences and/or a standard uptake volume (SUV max) of less than 1, 59 on positron emission tomography (PET) scanners at 6-fluoro-[18 fluoro]-L-dihydroxyphenylalanine (F-DOPA)

  3. Evaluation of overall survival

    Time frame: At each follow-up visits after preoperative SRS : +3 months (M3); +6 months (M6); +9 months (M9); +12 months (M12)

    defined as the time interval between the date of preoperative radiosurgery and the date of death from any cause.

  4. Evaluation of acute (less than 3 months post preoperative SRS) and delayed toxicities (more than 3 months after preoperative SRS)

    Time frame: At each follow-up visits after preoperative SRS : +3 months (M3); +6 months (M6); +9 months (M9); +12 months (M12)

    They will be collected and graded according to the NCI-CTCAE v5.0 scale. An adverse event of grade ≥ 3 will be considered "severe".

  5. Rate of leptomeningeal relapses

    Time frame: At each follow-up visits after preoperative SRS : +3 months (M3); +6 months (M6); +9 months (M9); +12 months (M12)

    According to cerebral MRI

  6. Evaluation of cerebral distant control

    Time frame: At each follow-up visits after preoperative SRS : +3 months (M3); +6 months (M6); +9 months (M9); +12 months (M12)

    Follow by MRI

  7. Determination of predictive factors for local brain control, complication and prognosis factors for survival

    Time frame: At each follow-up visits after preoperative SRS : +3 months (M3); +6 months (M6); +9 months (M9); +12 months (M12)

  8. Evaluation of cognitive function

    Time frame: At each follow-up visits after preoperative SRS : +3 months (M3); +6 months (M6); +9 months (M9); +12 months (M12)

    Mini-mental state examination (MMSE)

  9. Evaluation of quality of life

    Time frame: At each follow-up visits after preoperative SRS : +3 months (M3); +6 months (M6); +9 months (M9); +12 months (M12)

    European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-Core 30 (C30)

Sponsors and collaborators

Lead sponsor

Centre Jean Perrin

Other

Collaborators

  • Groupement Interrégional de Recherche Clinique et d'Innovation

Registry information

Official study title

Phase II Study to Assess Preoperative Hypofractionated Stereotactic Radiotherapy of Brain Metastases

Acronym: STEP

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
Aug 7, 2020
Registry last updated
Dec 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.