| 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 |
Traitement des tumeurs par champs électriques (TTFields) combiné à la gemcitabine et au nab-paclitaxel |
| Institution |
CENTRE HOSPITALIER DE L'UNIVERSITE DE MONTREAL
|
| Ville |
Montréal |
| Investigateur(trice) principal(e) |
Dr Richard Létourneau
|
| Coordonnateur(trice) |
Chantal Lefebvre
514-890-8000 poste 24532
|
| Statut |
![]() Fermé |
| 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.
|
Groupe d'étude en oncologie du Québec