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A Study of NovoTTF-200T(P) in Combination With Gemcitabine and Nab-Paclitaxel for Resectable Pancreatic Adenocarcinoma

ConditionsPancreatic AdenocarcinomaResectable Pancreatic Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorAshish Manne

About this trial

This is a single arm phase II study. All patients will receive 3 cycles of the treatment of nab-paclitaxel (Days 1, 8 and 15), gemcitabine (Days 1, 8 and 15), and TTFields (worn every day for at least 18 hours). Following the initial 3 cycles of gemcitabine/nab-paclitaxel/TTFields treatment, patients will undergo restaging by CT or MRI. Patients with stable disease or better will undergo surgery for resection within 8 weeks following completion of initial chemotherapy although enrolling sites are encouraged to perform resection within 4 weeks of Cycle 3 D15 of therapy. If resection yields R0 or R1, patients will begin an additional 3 cycles of gemcitabine/nab-paclitaxel/TTFields treatment within 8 weeks of surgery. Based on available literature, it is expected that a percentage of patients will not undergo resection either due to disease progression or due to toxicities/ complications of the neoadjuvant segment of therapy. These patients will be included in the evaluable patients for both co-primary endpoints as well as the secondary endpoints including ORR, adverse events, and OS.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Male or non-pregnant, non-lactating female age ≥ 18 years at the time of consent.

Karnofsky Performance Status (KPS) of ≥70% within 7 days prior to registration.

Histological or cytological evidence of pancreatic adenocarcinoma.

No involvement of the celiac artery, common hepatic artery, and superior mesenteric artery (and, if present, replaced right hepatic artery).

Disqualifiers

Evidence of distant metastasis

Patients with an electrical implantable device in the torso. Examples of electrical implanted medical devices include spinal cord stimulators, vagus nerve stimulators, pacemakers, and defibrillators.

History of significant uncontrolled cardiovascular disease. 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 -Known allergy to medical adhesives or conductive hydrogel (gel used on electrocardiogram (ECG) stickers or transcutaneous electrical nerve stimulation (TENS) electrodes).

Trial design

Design model

Single group

Treatments tested in this trial

  • Nab paclitaxel

    Drug

    125 mg/m\^2 IV over 30 minutes or per site standard on days 1, 8, and 15 of a 28 day cycle

  • Gemcitabine

    Drug

    1000 mg/m\^2 IV over 30 minutes or per site standard on days 1, 8, and 15 of a 28 day cycle

  • NovoTTF-200T(P)

    Device

    Worn \> 18 hr /day starting C1D1 until completion of cycle 3

Treatment groups

38 Participants
are divided into 1 treatment group
Group A: Investigational GroupExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

2 Year Overall Survival (OS)

Determine the two-year OS rate. Two-year (2-Y) OS will be calculated as the percentage of patients who remain alive at the 2 year mark from the registration date.

Time frame
2 years
2

Rate of Resection

Determine the rate of resection following the neoadjuvant treatment with TTFields in combination with chemotherapy. Resectability rate will be calculated as the proportion of evaluable patients undergoing R0 or R1 resection following the neoadjuvant segment of therapy.

Time frame
4 years

Secondary outcomes

1

Assess adverse events

Assess frequency and severity of adverse events when TTFields is added to gemcitabine and nab-paclitaxel chemotherapy using CTCAE v5 criteria. Adverse Events (AE): AEs and the maximum grade for each type of adverse events will be summarized for each patient separately for the following three periods: * During perioperative therapy * Complications during surgery and post-operative period for 30 days * During adjuvant therapy

Time frame
3 months, 5 months, and 10 months
2

Overall Response Rate (ORR)

Determine ORR. Overall response rate will include confirmed complete response (CR) + confirmed partial response (PR) and will be determined as per RECIST v1.1.

Time frame
4 years
3

Post Resection Disease Free Survival (DFS)

Estimate the post resection DFS. DFS will be estimated in patients undergoing resection and will be defined as the date of resection to the date of first documentation of recurrence (loco-regional or distant) or death due to any cause.

Time frame
4 years
4

Overall Survival (OS)

Estimate the median OS is defined as the time from initiation of therapy to death from any cause. OS will be assessed from date of registration till death from any cause on an intention to treat basis.

Time frame
4 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Ashish Manne

Lead sponsor

Big Ten Cancer Research Consortium

Sponsor institution

NovoCure GmbH

Collaborator

Ohio State University

Collaborator

Source ClinicalTrials.gov
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