Preoperative Stereotactic Radiosurgery for Brain Metastases

NCT04503772 | Completed Phase 2 DMC

• 2 other identifiers: 2020-A00403-3620.06.16-36701
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 8

Brief Summary

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

Conditions

Brain Metastases

Keywords

brain metastases; preoperative stereotactic radiosurgery; local control; radionecrosis; overall survival

Outcome Measures

Primary Outcomes (1)

• Evaluation of 6-months local control rate after preoperative SRS

  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.

  6 months after preoperative SRS (M6)

Secondary Outcomes (9)

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

  12 months after preoperative SRS (M12)

• Evaluation of 1-year radionecrosis rate after preoperative SRS

  12 months after preoperative SRS (M12)

• Evaluation of overall survival

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

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

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

• Rate of leptomeningeal relapses

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

Study Arms (1)

Experimental arm (all patients)

EXPERIMENTAL

Patients will receive preoperative hypofractionated stereotactic radiosurgery (SRS). According to the association of french-speaking neuro-oncologists (ANOCEF) recommendations, total dose and fractionation will be 33 Gy in 3 fractions at the isocenter, 23.1 Gy in envelope (70% isodose), i.e. 30 Gy in growth tumor volume (GTV) envelope.) Surgery will take place within 3 days of the preoperative SRS.

Procedure: Preoperative SRS

Interventions

Preoperative SRS PROCEDURE

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

Experimental arm (all patients)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≤ 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Jean Perrin: lead
• Groupement Interrégional de Recherche Clinique et d'Innovation (AURA): collaborator

Study Sites (8)

Centre Jean PERRIN

Clermont-Ferrand, Puy-de-Dôme, 63800, France

Location

CHU Grenoble Alpes

Grenoble, 38700, France

Location

Hospices Civils de Lyon

Lyon, 69002, France

Location

Centre Léon BÉRARD

Lyon, 69373, France

Location

Centre Hospitalier d'Annecy-Genevois

Metz-Tessy, 74370, France

Location

Institut de Cancérologie de l'Ouest

Saint-Herblain, France

Location

Institut de cancérologie de la Loire Lucien Neuwirth

Saint-Priest-en-Jarez, 42270, France

Location

Institut de cancérologie Strasbourg Europe (ICANS)

Strasbourg, 67000, France

Location

Related Publications (1)

• Ginzac A, Dupic G, Brun L, Molnar I, Casile M, Durando X, Verrelle P, Lemaire JJ, Khalil T, Biau J. Preoperative stereotactic radiosurgery for brain metastases: the STEP study protocol for a multicentre, prospective, phase-II trial. BMC Cancer. 2021 Jul 28;21(1):864. doi: 10.1186/s12885-021-08602-0.

  PMID: 34320940 RESULT

Related Links

• Study protocol article

MeSH Terms

Conditions

Brain Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Lucie BRUN, MD

  Centre Jean Perrin

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 4, 2020
• First Posted: August 7, 2020
• Study Start: February 4, 2021
• Primary Completion: May 19, 2025
• Study Completion: November 25, 2025
• Last Updated: December 4, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

FR (8)