PANOVA-3 Study for Patients with Locally-Advanced Pancreatic Adenocarcinoma

Clinical Trial Title

PANOVA-3: 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.

National Clinical Trial Number:

NCT03377491

Clinical Trial Protocol Description:

To test the efficacy and safety of gemcitabine and nab-paclitaxel, with or without TIFields, using the NovoTIF-lOOL(P) System as a front-line therapy for locally-advanced pancreatic adenocarcinoma patients.

Clinical Trial Eligibility Criteria:

In order to participate you must meet the following criteria:

  1. Are 18 years of age or older.
  2. Have a life expectancy of~ 3 months.
  3. Have histological/cytological diagnosis of de novo adenocarcinoma of the pancreas.
  4. Have unresectable, locally advanced stage disease according to following criteria:
    • Head/uncinate process:
      • Solid tumor contact with SMA>180o
      • Solid tumor contact with the CA>180°
      • Solid tumor contact with the first jejunal SMA branch
      • Unreconstructible SMV/PV due to tumor involvement or occlusion (can be d/t tumor or bland thrombus)
      • Contact with most proximal draining jejunal branch into SMV
    • Body and tail
      • Solid tumor contact of >180° with the SMA orCA
      • Solid tumor contact with the CA and aortic involvement
      • 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 AI-Hawary MM, et al., Radiology 2014)
  5. Have an ECOG score of 0-2.
  6. Are amenable and assigned by the investigator to receive therapy with gemcitabine and nabpaclitaxel.
  7. Are able to operate the NovoTTF-100L(P) System independently or with the help of a caregiver.
  8. Have signed informed consent form for the study protocol.

This is a partial list of elgibility requirements. To inquire about your eligibility, please call the contact number provided. If you wish to inquire via email, please include the title of the study in your message.

Study Details

Clinical Trial Investigator

Ashiq Masood, MD

Contact Information

Rush Cancer Center Clinical Trials Office