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)
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