Clinical trial NCT04503772: Preoperative Stereotactic Radiosurgery for Brain Metastases
Official title: Phase II Study to Assess Preoperative Hypofractionated Stereotactic Radiotherapy of Brain Metastases
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Brain Metastases
Keywords: brain metastases
preoperative stereotactic radiosurgery
local control
radionecrosis
overall survival
Lead sponsor: Centre Jean Perrin
Sponsor class: OTHER
Collaborators: name: Groupement Interrégional de Recherche Clinique et d'Innovation (AURA)
First posted: 2020-08-07
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


Eligibility 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

Primary outcomes:
measure: Evaluation of 6-months local control rate after preoperative SRS
timeFrame: 6 months after preoperative SRS (M6)
Secondary outcomes:
measure: Evaluation of 1-year local control rate after preoperative SRS
timeFrame: 12 months after preoperative SRS (M12)
measure: Evaluation of 1-year radionecrosis rate after preoperative SRS
timeFrame: 12 months after preoperative SRS (M12)
measure: Evaluation of overall survival
timeFrame: At each follow-up visits after preoperative SRS : +3 months (M3); +6 months (M6); +9 months (M9); +12 months (M12)
measure: Evaluation of acute (less than 3 months post preoperative SRS) and delayed toxicities (more than 3 months after preoperative SRS)
timeFrame: At each follow-up visits after preoperative SRS : +3 months (M3); +6 months (M6); +9 months (M9); +12 months (M12)
measure: Rate of leptomeningeal relapses
timeFrame: At each follow-up visits after preoperative SRS : +3 months (M3); +6 months (M6); +9 months (M9); +12 months (M12)
measure: Evaluation of cerebral distant control
timeFrame: At each follow-up visits after preoperative SRS : +3 months (M3); +6 months (M6); +9 months (M9); +12 months (M12)
measure: Determination of predictive factors for local brain control, complication and prognosis factors for survival
timeFrame: At each follow-up visits after preoperative SRS : +3 months (M3); +6 months (M6); +9 months (M9); +12 months (M12)
measure: Evaluation of cognitive function
timeFrame: At each follow-up visits after preoperative SRS : +3 months (M3); +6 months (M6); +9 months (M9); +12 months (M12)
measure: Evaluation of quality of life
timeFrame: At each follow-up visits after preoperative SRS : +3 months (M3); +6 months (M6); +9 months (M9); +12 months (M12)
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: Centre Jean PERRIN
state: Puy-de-Dôme
city: Grenoble
country: France
facility: CHU Grenoble Alpes
city: Lyon
country: France
facility: Hospices Civils de Lyon
city: Lyon
country: France
facility: Centre Léon BÉRARD
city: Metz-Tessy
country: France
facility: Centre Hospitalier d'Annecy-Genevois
city: Saint-Herblain
country: France
facility: Institut de Cancérologie de l'Ouest
city: Saint-Priest-en-Jarez
country: France
facility: Institut de cancérologie de la Loire Lucien Neuwirth
city: Strasbourg
country: France
facility: Institut de cancérologie Strasbourg Europe (ICANS)
Study officials:
affiliation: Centre Jean Perrin
name: Lucie BRUN, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.