Effect of Tumor Treating Fields (TTFields, 150 kHz) as Front-Line Treatment of Locally-advanced Pancreatic Adenocarcinoma Concomitant With Gemcitabine and Nab-paclitaxel (PANOVA-3)

Completed · Phase 3

Conditions studied: Pancreas Adenocarcinoma

In brief

Brief Summary: The study is a prospective, randomized controlled phase III trial aimed to test the efficacy and safety of Tumor Treating Fields (TTFields) in combination with gemcitabine and nab-paclitaxel, for front line treatment of locally-advanced pancreatic adenocarcinoma.The device is an experimental, portable, battery operated device for chronic administration of alternating electric fields (termed TTFields or TTF) to the region of the malignant tumor, by means of surface, insulated electrode arrays.

Key facts

Study ID: NCT03377491
Run by: NovoCure Ltd.
People needed: 571
Starts: 2018-05-10
Expected to finish: 2024-10-16
Last updated by the study team: 2026-01-21

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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-200T System independently or with the help of a caregiver
Signed informed consent form for the study protocol

You may not qualify if…

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.

Where it is running

Infirmary Cancer Care — Mobile, Alabama, United States
Banner MD Anderson Cancer Center — Gilbert, Arizona, United States
Arizona Oncology Associates, PC- HOPE - US Oncology Research — Tucson, Arizona, United States
University of Arizona Cancer Center — Tucson, Arizona, United States
Pacific Cancer Medical Center — Anaheim, California, United States
Providence Medical Foundation — Fullerton, California, United States
Cedars-Sinai Medical Center — Los Angeles, California, United States
Dignity Health - Mercy Cancer Centers — Sacramento, California, United States
Sutter Cancer Center Sacramento — Sacramento, California, United States
Ridley-Tree Cancer Center — Santa Barbara, California, United States
Adventist Health St. Helena - Martin-O'Neil Cancer Center (MOCC) — St. Helena, California, United States
Associated Neurologists of Southern Connecticut, P.C. — Milford, Connecticut, United States
Boca Raton Regional Hospital, Lynn Cancer Institute — Boca Raton, Florida, United States
Cancer Specialist of North Florida — Fleming Island, Florida, United States
Florida Cancer Specialists & Research Institute - Colonial Office — Fort Myers, Florida, United States
Mayo Clinic Hospital - Florida — Jacksonville, Florida, United States
Mount Sinai Medical Center — Miami Beach, Florida, United States
AdventHealth Neuro Oncology — Orlando, Florida, United States
BRCR Medical Center INC — Plantation, Florida, United States
Florida Cancer Specialists — St. Petersburg, Florida, United States
Florida Hospital Tampa — Tampa, Florida, United States
Piedmont Cancer Institute — Atlanta, Georgia, United States
Illinois Cancer Specialist - US Oncology Research — Arlington Heights, Illinois, United States
Rush University Medical Center — Chicago, Illinois, United States
Grandview Medical Center, Cancer Center — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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