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Gemcitabine, Cisplatin and Nab-Paclitaxel as Neoadjuvant Treatment for Patients With Resectable or Borderline Resectable Pancreatic Cancer

StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 8 months later Dec 31, 2026 → Aug 31, 2027
See other at-risk trials from Georgetown University

Record History

  1. Primary completion pushed from Dec 31, 2026 to Aug 31, 2027 Sponsor changed: Emory University to Georgetown University · Study sites: 1 to 2 · Eligibility criteria expanded, about 58 words · 3 more Show 6 more changesShow less
    • Sponsor changed: Emory University to Georgetown University
    • Study sites: 1 to 2
    • Eligibility criteria expanded, about 58 words
    • Secondary endpoints: details revised at 6 of 10 entries
    • Collaborators: 2 to 1
    • Study description shortened, about 4 words
  2. Primary completion date: Dec 31, 2025 to Dec 31, 2026 Completion date: Dec 31, 2026 to Dec 31, 2027 · Site contact updatedv6 Show 2 more changesShow less
    • Completion date: Dec 31, 2026 to Dec 31, 2027
    • Site contact updated
  3. Primary endpoint revised Enrollment target: 44 to 36 · Secondary endpoints: 8 to 10 · Site contact updatedv5 Show 3 more changesShow less
    • Enrollment target: 44 to 36
    • Secondary endpoints: 8 to 10
    • Site contact updated

    See this version in full on ClinicalTrials.gov ↗

  4. Site contact updated Collaborators: 1 to 2v4 Show 1 more changeShow less
    • Collaborators: 1 to 2

    See this version in full on ClinicalTrials.gov ↗

  5. Trial status: Not Yet Recruiting to Recruiting Start date changed from estimate of Aug 1, 2024 to Aug 6, 2024 · Site details revisedv3 Show 2 more changesShow less
    • Start date changed from estimate of Aug 1, 2024 to Aug 6, 2024
    • Site details revised
  6. Start date: Jul 1, 2024 to Aug 1, 2024v2
  7. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
This phase II trial tests how well gemcitabine, cisplatin and nab-paclitaxel given before surgery (neoadjuvant) works in treating patients with pancreatic cancer that can be removed by surgery (resectable) or that is borderline resectable. The standard treatment for resectable and borderline resectable pancreatic cancer is a combination of surgery and chemotherapy. Neoadjuvant therapy is more feasible and could improve outcomes compared to patients receiving surgery first. Gemcitabine is a chemotherapy drug that blocks the cells from making DNA and may kill tumor cells. Cisplatin is in a class of medications known as platinum-containing compounds. It works by killing, stopping or slowing the growth of tumor cells. Nab-paclitaxel is an albumin-stabilized nanoparticle formulation of paclitaxel, an antimicrotubule agent that stops tumor cells from growing and dividing and may kill them. Nab-paclitaxel may have fewer side effects and work better than other forms of paclitaxel. Gemcitabine, cisplatin and nab-paclitaxel may be an effective neoadjuvant treatment option for patients with resectable or borderline resectable pancreatic cancer.
Trial Details
NCT Number NCT06423326
Lead Sponsor Georgetown University
Collaborators: Emory University
Conditions Borderline Resectable Pancreatic Ductal Adenocarcinoma, Resectable Pancreatic Adenocarcinoma, Stage I Pancreatic Cancer AJCC v8, Stage II Pancreatic Cancer AJCC v8, Stage III Pancreatic Cancer AJCC v8
Enrollment 36 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov