Titre Pivotal, Open-label, Randomized Study of Radiosurgery With or Without Tumor Treating Fields (TTFields) (150kHz) for 1-10 Brain Metastases From Non-small Cell Lung Cancer (NSCLC)
Protocole ID Metis (EF-25)
ClinicalTrials.gov ID NCT02831959
Type(s) de cancer Poumon non à petites cellules
Phase Phase III
Stade Métastatique
Type étude Traitement
Institution CENTRE HOSPITALIER DE L'UNIVERSITE DE MONTREAL  
Ville Montréal
Investigateur(trice) principal(e) Dr David Roberge
Coordonnateur(trice) Diane Trudel
 514-890-8000 poste 11181
Statut Fermé
Date d'activation 04-07-2017
Critètes d'éligibilité
  • 18 years of age and older
  • Life expectancy of ≥ 3 months
  • New diagnosis of brain metastases from a histologically or cytologically confirmed primary or metastatic NSCLC tumor within 5 years of registration on the study. If the original histological proof of malignancy is greater than 5 years, then pathological confirmation is required (i.e.: from extra-cranial or intracranial disease).
  • Karnofsky performance status (KPS) ≥ 70
  • Graded Prognostic Assessment (GPA) score ≥ 2.0
  • 1 inoperable brain metastasis or 2- 10 brain lesions per screening MRI, confirmed by contrast enhanced MRI amenable to SRS
  • At least one measurable lesion per RANO-BM (Response Assessment in Neuro-Oncology Brain Metastases) Criteria for brain metastasis
  • Patients must be receiving optimal therapy for their extracranial disease according to local practice at each center. Patients may continue on systemic therapy while receiving TTFields.
  • Able to operate the NovoTTF-100M device independently or with the help of a caregiver
  • Clinical trials prior to enrollment are allowed, as long as no brain directed therapy was included (current treatment trials are exclusionary)
Critètes d'exclusion
  • Patients who are known to have somatic tumor mutations in the following genes, for which targeted agents are available that directly affect the treatment of brain metastasis: Anaplastic lymphoma kinase (ALK), epidermal growth factor receptor (EGFR), ROS-1 proto-oncogene, and proto-oncogene B-RAF
  • Patients who have a single, operable brain metastasis
  • Patients with significant edema leading to risk of brain herniation
  • Patients with midline shift > 10mm
  • Patients with intractable seizures
  • Infratentorial metastases
  • Leptomeningeal metastases
  • Recurrent brain metastases or brain metastases previously treated with surgery and/or radiosurgery and/or brain radiotherapy
  • Prior surgical resection or WBRT for newly diagnosed brain metastases (needle biopsy for diagnosis establishment is allowed)
  • Severe comorbidities:
    • Clinically-significant inadequate hematological, hepatic and renal function, defined as: Neutrophil count < 1.5 x 10 9/L and platelet count < 100 x 10^9/L; bilirubin > 1.5 x upper limit of normal (ULN); aspartate transaminase (AST) and/or alanine aminotransferase (ALT) > 2.5 x ULN or > 5 x ULN if patient has documented liver metastases; and serum creatinine > 1.5 x ULN
    • History of significant cardiovascular disease unless the disease is well controlled. Significant cardiac disease includes second/third degree heart block; significant ischemic heart disease; poorly controlled hypertension; congestive heart failure of the New York Heart Association (NYHA) Class II or worse (slight limitation of physical activity; comfortable at rest, but ordinary activity results in fatigue, palpitation or dyspnea).
    • History of arrhythmia that is symptomatic or requires treatment. Patients with atrial fibrillation or flutter controlled by medication are not excluded from participation in the trial.
    • History of cerebrovascular accident (CVA) within 6 months prior to randomization or that is not stable
    • Active infection or serious underlying medical condition that would impair the ability of the patient to received protocol therapy
    • History of any psychiatric condition that might impair patient's ability to understand or comply with the requirements of the study or to provide consent
  • Implantable electronic medical devices in the brain
  • Known allergies to medical adhesives or hydrogel
  • Currently pregnant or breastfeeding
  • Concurrent brain directed therapy (beyond SRS and NovoTTF-100M as per protocol)