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A Pivotal Study of Safety and Effectiveness of NanoKnife IRE for Stage 3 Pancreatic Cancer

Study acronym: DIRECT
StatusActive, Not Recruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated February 12, 2025 (before its estimated April 2025 completion). Its status may not reflect the trial's current state.

Record History

  1. Primary and study completion dates: Dec 2023 to Apr 2025
    • Trial status: Recruiting to Active, Not Recruiting
    • Site details revised at 6 of 6 sites
    v10
  2. Study sites: 12 to 6v9
  3. Start date changed from estimate of Jul 2020 to Feb 23, 2021
    • Study sites: 9 to 12
    v8
  4. Study sites: 8 to 9v7
  5. Study sites: 4 to 8v6
Show 4 earlier versionsHide 4 earlier versions
  1. Start date: Mar 2020 to Jul 2020v5
  2. Start date: Dec 2019 to Mar 2020
    • Study sites: 2 to 4
    v4
  3. Trial status: Not Yet Recruiting to Recruiting
    • Start date: May 2019 to Dec 2019
    • Study sites: 0 to 2
    v3
  4. Re-verified, no change to tracked fieldsv2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Subjects will be offered the opportunity to participate in a randomized, controlled, 2-arm, unblinded multicenter trial (RCT). There will be 2 study arms: the control arm receiving chemotherapy with the modified FOLFIRINOX regimen alone; and the irreversible electroporation (IRE) arm, receiving chemotherapy with the modified FOLFIRINOX regimen followed by IRE with the NanoKnife System using either an open or a percutaneous approach. All subjects will be treated with the modified FOLFIRINOX regimen for at least 3 months; randomization to either control or IRE arm will take place at the time of completion of the 3 month modified FOLFIRINOX chemotherapy regimen. Randomization will be conducted centrally. Subjects will be randomized in a 1:1 ratio and must be found to have no evidence of disease progression after completion of the 3 month modified FOLFIRINOX chemotherapy regimen in order to participate in the RCT. All radiologic assessments will be performed as consistent with the imaging protocol. All post induction and post IRE treatments are left to the discretion of the treating physician. The minimum period of follow-up will be for 24 months or until death.
Trial Details
NCT Number NCT03899636
Lead Sponsor Angiodynamics, Inc.
Conditions
(from sponsor)		 Stage III Pancreatic Cancer
Related terms Carcinoma, Pancreatic Ductal, Pancreatic Neoplasms
Enrollment 528 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov