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
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.
DiagnosisLocally-advanced, unresectable adenocarcinoma of the pancreas.
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.
- 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.
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