Status:
COMPLETED
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)
Lead Sponsor:
NovoCure Ltd.
Conditions:
Pancreas Adenocarcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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-pacl...
Detailed Description
PAST PRE-CLINICAL AND CLINICAL EXPERIENCE: The effect of the electric fields (TTFields, TTF) has demonstrated significant activity in in vitro and in vivo pancreatic adenocarcinoma pre-clinical model...
Eligibility Criteria
Inclusion
- 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
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.
Key Trial Info
Start Date :
February 10 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 16 2024
Estimated Enrollment :
571 Patients enrolled
Trial Details
Trial ID
NCT03377491
Start Date
February 10 2018
End Date
October 16 2024
Last Update
October 31 2024
Active Locations (199)
Enter a location and click search to find clinical trials sorted by distance.
1
Grandview Medical Center, Cancer Center
Birmingham, Alabama, United States, 35243
2
Infirmary Cancer Care
Mobile, Alabama, United States, 36607
3
Banner MD Anderson Cancer Center
Gilbert, Arizona, United States, 85234
4
Arizona Oncology Associates, PC- HOPE - US Oncology Research
Tucson, Arizona, United States, 85711