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)

• Register: ClinicalTrials.gov
• Last refreshed on: 17 April 2023
• Main ID: NCT03377491
• Date of registration: 06/12/2017
• Prospective Registration: Yes
• Primary sponsor: NovoCure Ltd.
• Public title: 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)
• Scientific title: 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
• Date of first enrolment: February 10, 2018
• Target sample size: 556
• Recruitment status: Active, not recruiting
• URL: https://clinicaltrials.gov/show/NCT03377491
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 3

Countries of recruitment

Australia, Austria, Belgium, Brazil, Canada, China, Croatia, Czechia, France, Germany, Hong Kong, Hungary, Israel, Italy, Korea, Republic of, Mexico, Poland, Spain, Switzerland, United States

Key inclusion & exclusion criteria

Inclusion Criteria:

1. 18 years of age and older

2. Life expectancy of = 3 months

3. Histological/cytological diagnosis of de novo adenocarcinoma of the pancreas

4. Unresectable, locally advanced stage disease according to the following criteria:

- Head/uncinate process:

1. Solid tumor contact with SMA>180°

2. Solid tumor contact with the CA>180°

3. Solid tumor contact with the first jejunal SMA branch

4. Unreconstructible SMV/PV due to tumor involvement or occlusion (can be d/t
tumor or bland thrombus)

5. Contact with most proximal draining jejunal branch into SMV

- Body and tail

1. Solid tumor contact of >180° with the SMA or CA

2. Solid tumor contact with the CA and aortic involvement

3. 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)

5. ECOG score 0-2

6. Amenable and assigned by the investigator to receive therapy with gemcitabine and
nab-paclitaxel

7. Able to operate the NovoTTF-200T System independently or with the help of a caregiver

8. Signed informed consent form for the study protocol

Exclusion Criteria:

1. Prior palliative treatment (e.g. surgery, radiation) to the tumor

2. 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.

3. Serious co-morbidities:

1. 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.

2. 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).

3. 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.

4. History of cerebrovascular accident (CVA) within 6 months prior to randomization
or that is not stable.

5. Active infection or serious underlying medical condition that would impair the
ability of the patient to receive protocol therapy.

6. 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.

4. Concurrent anti-tumor therapy beyond gemcitabine and nab-paclitaxel

5. Implantable electronic medical devices in the torso, such as pacemakers

6. Known severe hypersensitivities to medical adhesives or hydrogel, or to one of the
chemotherapies used in this trial.

7. 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.

8. Unable to follow the protocol for medical, psychological, familial, geographic or
other reasons.

9. Admitted to an institution by administrative or court order.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Pancreas Adenocarcinoma

Intervention(s)

Device: NovoTTF-200T

Drug: nab paclitaxel

Drug: Gemcitabine

Primary Outcome(s)

Overall survival [Time Frame: 4 years]

Secondary Outcome(s)

Resectability rate [Time Frame: 4 years]

Local progression-free survival [Time Frame: 4 years]

Objective response rate [Time Frame: 4 years]

Progression-free survival [Time Frame: 4 years]

One-year survival rate [Time Frame: 4 years]

Quality of life [Time Frame: 4 years]

Puncture-free survival [Time Frame: 4 years]

Pain-free survival [Time Frame: 4 years]

Toxicity profile [Time Frame: 4 years]

Secondary ID(s)

EF-27

Source(s) of Monetary Support

Please refer to primary and secondary sponsors