A Study of NovoTTF-200T(P) in Combination With Gemcitabine and Nab-Paclitaxel for Resectable Pancreatic Adenocarcinoma

This is a single arm phase II study. All patients will receive 3 cycles of the treatment of nab-paclitaxel (Days 1, 8 and 15), gemcitabine (Days 1, 8 and 15), and TTFields (worn every day for at least 18 hours). Following the initial 3 cycles of gemcitabine/nab-paclitaxel/TTFields treatment, patients will undergo restaging by CT or MRI. Patients with stable disease or better will undergo surgery for resection within 8 weeks following completion of initial chemotherapy although enrolling sites are encouraged to perform resection within 4 weeks of Cycle 3 D15 of therapy. If resection yields R0 o

Trial Details

NCT ID
NCT05624918
Phase
PHASE2
Sponsor
Ashish Manne
Status
RECRUITING
Cancer Type
Pancreatic Cancer
Interventions
  • Nab paclitaxel
  • Gemcitabine
  • NovoTTF-200T(P)
Locations (sample)
  • Columbus, Ohio, United States|39.96118,-82.99879

Key Eligibility Criteria

  • Written informed consent and HIPAA authorization for release of personal health information.
  • NOTE: HIPAA authorization may be included in the informed consent or obtained separately.
  • Male or non-pregnant, non-lactating female age ≥ 18 years at the time of consent.
  • Karnofsky Performance Status (KPS) of ≥70% within 7 days prior to registration.

For full eligibility, visit ClinicalTrials.gov.

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