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Novocure PANOVA-3

Trial Overview

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

Study Purpose

To evaluate the efficacy and safety of TTFields together with standard chemotherapy (gemcitabine and nab-paclitaxel) compared to standard chemotherapy (gemcitabine and nab-paclitaxel) without TTFields. 

Diagnosis

Locally-advanced, unresectable adenocarcinoma of the pancreas.

Eligibility

No palliative treatment (e.g. surgery, radiation) to the tumor.

No concurrent anti-tumor therapy beyond gemcitabine and nab-paclitaxel.

Patients must sign an approved informed consent and authorization permitting release of personal health information.

Intervention

  • ARM I:  Will receive standard chemotherapy (gemcitabine and nab-paclitaxel) in combination with TTFields.
  • ARM II:  Will receive standard chemotherapy (gemcitabine and nab-paclitaxel) alone.
  • The NovoTTF-100L(P) system is a portable, battery operated device which delivers TTFields at 150 kHz to patients by means of insulated Transducer Arrays.
  • Device should be worn for at least 18 hours a day. Patients may take breaks for personal needs.

For more information, visit ClinicalTrials.gov

Key Participation Requirements
Gender
Male or Female
Age
19 years and older
Phase
Phase III
Methodist Health System Trial Code
Panova-3
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