(EF-27) (PANOVA-3): Pivotal, randomized, open-label study of Tumor Treating Fields (TTFields, 150kHz) con-comitant with gemcitabine and nab-paclitaxel for front-line treatment of locally-advanced pancreatic adenocarcinoma
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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:
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- 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
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- Body and tail
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- 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)
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- 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
Exclusion Criteria:
- 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.