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Preoperative Stereotactic Radiosurgery for Brain Metastases (STEP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04503772
Recruitment Status : Recruiting
First Posted : August 7, 2020
Last Update Posted : April 8, 2022
Sponsor:
Collaborator:
Groupement Interrégional de Recherche Clinique et d'Innovation (AURA)
Information provided by (Responsible Party):
Centre Jean Perrin

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

Condition or disease Intervention/treatment Phase
Brain Metastases Procedure: Preoperative SRS Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study to Assess Preoperative Hypofractionated Stereotactic Radiotherapy of Brain Metastases
Actual Study Start Date : February 4, 2021
Estimated Primary Completion Date : January 2023
Estimated Study Completion Date : July 2023

Arm Intervention/treatment
Experimental: Experimental arm (all patients)

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




Primary Outcome Measures :
  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 Outcome Measures :
  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)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04503772


Contacts
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Contact: Angeline GINZAC COUVÉ, PhD 0463663337 ext +33 angeline.ginzac@clermont.unicancer.fr

Locations
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France
Centre Jean PERRIN Recruiting
Clermont-Ferrand, Puy-de-Dôme, France, 63800
Contact: Lucie BRUN, MD       lucie.brun@clermont.unicancer.fr   
Contact: Julian BIAU, MD, PhD       julian.biau@clermont.unicancer.fr   
Principal Investigator: Julian BIAU, MD, PhD         
Sub-Investigator: Lucie BRUN, MD         
Sub-Investigator: Juliette MOREAU, MD         
Sub-Investigator: Jessica MIROIR, MD         
CHU Grenoble Alpes Recruiting
Grenoble, France, 38700
Contact: Andréa DESAGNEAUX, MD         
Principal Investigator: Andréa DESAGNEAUX, MD         
Hospices Civils de Lyon Recruiting
Lyon, France, 69002
Contact: Anne d'Hombres, MD         
Principal Investigator: Anne d'Hombres, MD         
Centre Léon BÉRARD Recruiting
Lyon, France, 69373
Contact: Coralie MONCHARMONT, MD         
Principal Investigator: Coralie MONCHARMONT, MD         
Centre Hospitalier d'Annecy-Genevois Recruiting
Metz-Tessy, France, 74370
Contact: Alexandre TESSIER, MD         
Principal Investigator: Alexandre TESSIER, MD         
Institut de Cancérologie de l'Ouest Recruiting
Saint-Herblain, France
Contact: François THYLLAYS, MD         
Principal Investigator: François THYLLAIS, MD         
Institut de cancérologie de la Loire Lucien Neuwirth Not yet recruiting
Saint-Priest-en-Jarez, France, 42270
Contact: Nicolas MAGNÉ, Pr         
Principal Investigator: Nicolas MAGNÉ, Pr         
Institut de cancérologie Strasbourg Europe (ICANS) Recruiting
Strasbourg, France, 67000
Contact: Clara LEFEVRE, MD         
Principal Investigator: Clara LEFEVRE, MD         
Sponsors and Collaborators
Centre Jean Perrin
Groupement Interrégional de Recherche Clinique et d'Innovation (AURA)
Investigators
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Principal Investigator: Lucie BRUN, MD Centre Jean Perrin
Additional Information:
Publications:
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Responsible Party: Centre Jean Perrin
ClinicalTrials.gov Identifier: NCT04503772    
Other Study ID Numbers: 2020-A00403-36
20.06.16-36701 ( Other Identifier: Ethics committee Sud-Ouest et Outre-Mer IV )
First Posted: August 7, 2020    Key Record Dates
Last Update Posted: April 8, 2022
Last Verified: April 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Centre Jean Perrin:
brain metastases
preoperative stereotactic radiosurgery
local control
radionecrosis
overall survival
Additional relevant MeSH terms:
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Neoplasm Metastasis
Brain Neoplasms
Neoplastic Processes
Neoplasms
Pathologic Processes
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases