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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)

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ClinicalTrials.gov Identifier: NCT03377491
Recruitment Status : Recruiting
First Posted : December 19, 2017
Last Update Posted : June 26, 2020
Sponsor:
Information provided by (Responsible Party):
NovoCure Ltd.

Study Description
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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-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.


Condition or disease Intervention/treatment Phase
Pancreas Adenocarcinoma Device: NovoTTF-100L(P) Drug: Gemcitabine Drug: nab paclitaxel Phase 3

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Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 556 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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
Actual Study Start Date : May 10, 2018
Estimated Primary Completion Date : September 2023
Estimated Study Completion Date : September 2023

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Arms and Interventions
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Arm Intervention/treatment
Experimental: NovoTTF-100L(P)
Patients receive TTFields using the NovoTTF-100L(P) System together with gemcitabine and nab-Paclitaxel
 Device: NovoTTF-100L(P)
Patients receive continuous TTFields treatment using the NovoTTF-100L(P) device. TTFields treatment will consist of wearing four electrically insulated electrode arrays on the torso. The treatment enables the patient to maintain regular daily routine.
Other Name: TTFields

Drug: Gemcitabine
Gemcitabine 1000 mg/m^2 over 30 minute infusion will be administered immediately after nab-paclitaxel on Days 1, 8 and 15 of each 28-day cycle.

Drug: nab paclitaxel
nab-paclitaxel 125 mg/m^2 administered as an intravenous infusion over 30-40 minutes on Days 1, 8 and 15 of each 28-day cycle.
Active Comparator: Best Standard of Care
Patients receive best standard of care with gemcitabine and nab-Paclitaxel
 Drug: Gemcitabine
Gemcitabine 1000 mg/m^2 over 30 minute infusion will be administered immediately after nab-paclitaxel on Days 1, 8 and 15 of each 28-day cycle.

Drug: nab paclitaxel
nab-paclitaxel 125 mg/m^2 administered as an intravenous infusion over 30-40 minutes on Days 1, 8 and 15 of each 28-day cycle.


Outcome Measures
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Primary Outcome Measures :
  1. Overall survival [ Time Frame: 4 years ]

Secondary Outcome Measures :
  1. Progression-free survival [ Time Frame: 4 years ]
  2. Local progression-free survival [ Time Frame: 4 years ]
  3. Objective response rate [ Time Frame: 4 years ]
  4. One-year survival rate [ Time Frame: 4 years ]
  5. Quality of life [ Time Frame: 4 years ]
    Quality of life will be assessed using the EORTC QLQ C-30 questionnaire with EORTC QLQ-PAN26 (Pancreatic Cancer symptom) supplement.

  6. Pain-free survival [ Time Frame: 4 years ]
    Pain-free survival will measured as the duration between the time of randomization until a greater than or equal to two-point decline from a baseline measurement in a patient self-reported visual analogue scale (VAS) is recorded or death, whichever occurs first.

  7. Puncture-free survival [ Time Frame: 4 years ]
  8. Resectability rate [ Time Frame: 4 years ]
  9. Toxicity profile [ Time Frame: 4 years ]
    Toxicity profile in patients treated with TTFields in combination with gemcitabine and nab-paclitaxel compared to the toxicity profile of patients treated with chemotherapy alone, measured by the rate of treatment-emergent toxicities in both arms. Adverse events will be collected and recorded based on the revised Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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-100L(P) 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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03377491


Contacts
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Contact: Antonia Mahnig clinicaltrials@novocure.com

Locations
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Sponsors and Collaborators
NovoCure Ltd.
More Information
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Publications:

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Responsible Party: NovoCure Ltd.
ClinicalTrials.gov Identifier: NCT03377491    
Other Study ID Numbers: EF-27
First Posted: December 19, 2017    Key Record Dates
Last Update Posted: June 26, 2020
Last Verified: June 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Keywords provided by NovoCure Ltd.:
Locally Advanced Pancreatic Adenocarcinoma
TTFields
Tumor Treating Fields
Gemcitabine
 nab-Paclitaxel
Minimal toxicity
TTF
Novocure
Additional relevant MeSH terms:
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Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Gemcitabine
Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
 Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antimetabolites
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs