Titre Pivotal, Randomized, Open-label Study of Tumor Treating Fields (TTFields, 150kHz) Concomitant With Gemcitabine and Nab-paclitaxel for Front-line Treatment of Locally-advanced Pancreatic Adenocarcinoma
Protocole ID PANOVA-3
ClinicalTrials.gov ID NCT03377491
Type(s) de cancer Pancréas
Phase Phase III
Stade Localement avancé
Type étude Traitement
Médicament Tumor Treating Fields (TTFields) en combinaison avec gemcitabine et nab-paclitaxel
Institution CIUSSS DE L'ESTRIE – CENTRE HOSP. UNIV. DE SHERBROOKE
   HOPITAL FLEURIMONT
      3001 12e Avenue Nord, Sherbrooke, QC, J1H 5N4
Ville Sherbrooke
Investigateur(trice) principal(e) Dr Frédéric Lemay
Coordonnateur(trice) Michelle Roy
819-346-1110 poste 12848
Statut Actif en recrutement
Critètes d'éligibilité
  • 18 years of age and older
  • Life expectancy of ≥ 3 months
  • Histological/cytological diagnosis of de novo adenocarcinoma of the pancreas
  • Unresectable, locally advanced stage disease according to the following criteria:
  • Head/uncinate process:
  • Solid tumor contact with SMA>180°
  • Solid tumor contact with the CA>180°
  • Solid tumor contact with the first jejunal SMA branch
  • Unreconstructible SMV/PV due to tumor involvement or occlusion (can be d/t tumor or bland thrombus)
  • Contact with most proximal draining jejunal branch into SMV
  • Body and tail
  • Solid tumor contact of >180° with the SMA or CA
  • Solid tumor contact with the CA and aortic involvement
  • Unreconstructible SMV/PV due to tumor involvement or occlusion (can be d/t tumor or bland thrombus)
  • No distant metastasis, including non-regional lymph node metastasis
  • No borderline resectable (per Al-Hawary MM, et al., Radiology 201414)
  • ECOG score 0-2
  • Amenable and assigned by the investigator to receive therapy with gemcitabine and nab-paclitaxel
  • Able to operate the NovoTTF-100L(P) System independently or with the help of a caregiver
  • Signed informed consent form for the study protocol
Critètes d'exclusion
  • Prior palliative treatment (e.g. surgery, radiation) to the tumor
  • Cancer requiring anti-tumor treatment within the 5 years before inclusion, excluding treated stage I prostate cancer, in situ cervical or uterus cancer, in situ breast cancer and non-melanomatous skin cancer.
  • Serious co-morbidities:
  • Clinically significant (as determined by the investigator) hematological, hepatic and renal dysfunction, 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); AST and/or ALT > 2.5 x ULN; 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 receive 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.
  • Concurrent anti-tumor therapy beyond gemcitabine and nab-paclitaxel
  • Implantable electronic medical devices in the torso, such as pacemakers
  • Known severe hypersensitivities to medical adhesives or hydrogel, or to one of the chemotherapies used in this trial.
  • Pregnancy or breast-feeding (female patients with reproductive potential and their partners must accept to use effective contraception throughout the entire study period and for 3 months after the end of treatment). All patients who are capable of becoming pregnant must take a pregnancy test which is negative within 72 hours before beginning treatment. The definition of effective contraception is left up to the decision of the investigator.
  • Unable to follow the protocol for medical, psychological, familial, geographic or other reasons.
  • Admitted to an institution by administrative or court order.