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A Phase II Randomized Study of Gemcitabine and Nab-paclitaxel in Combination With S- 1/LV (GASL) or Oxaliplatin (GAP) as First-line Treatment for Metastatic Pancreatic Cancer

StatusActive, Not Recruiting
PhasePhase 2
Started
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Record History

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  1. Re-verified, no change to tracked fieldsv10
  2. Primary completion date: Dec 31, 2025 to Dec 2027
    • Study completion date: Dec 31, 2027 to Dec 2027
    v9
  3. Primary completion date: Dec 31, 2024 to Dec 31, 2025v8
  4. Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: 86 to 66
    • Site details revised at 4 of 4 sites
    v7
  5. Primary endpoint revisedv6 Show 4 more changesShow less
    • Study sites: 3 to 4
    • Eligibility criteria expanded, about 32 words
    • Study description expanded, about 111 words
    • Collaborators: 3 to 4
Show 4 earlier versionsHide 4 earlier versions
  1. Re-verified, no change to tracked fieldsv5
  2. Eligibility criteria expanded, about 15 words
    • Site details revised at 1 of 3 sites
    v4
  3. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Dec 31, 2021 to Dec 28, 2021
    • Site details revised at 3 of 3 sites
    v3
  4. Start date: Oct 1, 2021 to Dec 31, 2021
    • Interventions: Gemcitabine (Drug), S-1 (Drug), leucovorin (Drug), nab-paclitaxel (Drug), oxaliplatin (Drug) to Gemcitabine 1000 mg (Drug), Nab paclitaxel (Drug), Oxaliplatin (Drug), S1 (Drug), leucovorin (Drug)
    • Secondary endpoints revised (5)
    • Site contacts updated at 1 of 3 sites
    v2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Gemcitabine and nab-paclitaxel are one standard of care for metastatic pancreatic adenocarcinoma (mPDAC) but the progression free survival (PFS) of the regimen is only 5.5 months. Previous phase II study showed gemcitabine and nab-paclitaxel plus cisplatin had a PFS of 10.1 months in mPDAC. This study will evaluate the efficacy and safety of gemcitabine, nab-paclitaxel plus S-1/LV (GASL) against gemcitabine, nab-paclitaxel plus oxaliplatin (GAP) in patients with mPDAC.
Trial Details
NCT Number NCT05026905
Lead Sponsor National Health Research Institutes, Taiwan
Collaborators: China Medical University Hospital, National Cheng-Kung University Hospital, Kaohsiung Medical University Chung-Ho Memorial Hospital, Taichung Veterans General Hospital
Conditions
(from sponsor)		 Phase II, Open-label, Parallel 2-arm, Multi-center
Related terms Pancreatic Neoplasms
Enrollment 66 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov