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PANOVA-3

Status:

Recruiting | Phase III 

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:

The purpose of this study is 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. 

Interventions:

  •  ARM I:  Patients will receive standard chemotherapy (gemcitabine and nab-paclitaxel) in combination with TTFields.
  • ARM II:  Patients 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.

Key Participation Requirements:

Gender:

Male or Female

Age:

19 years and older

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.

Methodist Health System Trial Code:

Panova-3

For more information, visit the U.S. National Library of Medicine clinical trial database.

To learn more about this clinical trial please contact us today!