Hyperthermic Intraperitoneal Chemotherapy for the Treatment of Pancreatic Cancer and Peritoneal Metastasis

StatusActive, Not Recruiting
PhasePhase 2
Started

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Trial flagged as At Risk
Primary completion moved at least 1 year 2 months later Jul 2029 → Sep 30, 2030
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Record History

See every version on ClinicalTrials.gov ↗

  1. Notable Primary and study completion pushed from Jul 2029 to Sep 30, 2030 Show 5 more changesShow less
    • Enrollment closed, study ongoing
    • Secondary endpoints: details revised at 1 of 1 entry
    • Site details revised
    • Publications: details revised at 1 of 1 entry
    • Eligibility criteria shortened, about 5 words
  2. Minor Site contact updatedv18
  3. Notable Primary completion date: May 2026 to Jul 2029
    • Study completion date: May 2027 to Jul 2029
    • Site contact updated
    v17
  4. Notable Primary completion date: May 2025 to May 2026
    • Start date: Jan 5, 2024 to Feb 15, 2024
    • Study completion date: May 2026 to May 2027
    • Site contact updated
    v16
  5. Notable Primary endpoints: 3 to 2
    • Interventions: Cisplatin (Drug), Hyperthermic Intraperitoneal Chemotherapy (Drug), Nab-paclitaxel (Drug) to Cisplatin (Drug), Computed Tomography (Procedure), Hyperthermic Intraperitoneal Chemotherapy (Drug), Magnetic Resonance Imaging…
    • Study description expanded, about 13 words
    • Secondary endpoints expanded, about 1 word
    v15
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  1. Notable Trial status: Not Yet Recruiting to Recruiting
    • Primary endpoints: 9 to 3
    • Start date changed from estimate of Feb 2024 to Jan 5, 2024
    • Site details revised
    v14
  2. Notable Start date: Dec 2023 to Feb 2024
    • Site contact updated
    • Collaborators shortened, about 4 words
    v13
  3. Notable Start date: Jun 27, 2023 to Dec 2023
    • Primary completion date: May 31, 2025 to May 2025
    • Study completion date: May 31, 2026 to May 2026
    v12
  4. Notable Start date: Mar 27, 2023 to Jun 27, 2023v11
  5. Notable Start date: Feb 15, 2023 to Mar 27, 2023v10 Show 4 more changesShow less
    • Interventions: Cisplatin (Drug), Hyperthermic Intraperitoneal Chemotherapy (Drug), Paclitaxel (Drug) to Cisplatin (Drug), Hyperthermic Intraperitoneal Chemotherapy (Drug), Nab-paclitaxel (Drug)
    • Study description revised
    • Site contact updated
    • Collaborators expanded, about 4 words
  6. Notable Start date: Dec 15, 2022 to Feb 15, 2023
    • Collaborators shortened, about 4 words
    v9
  7. Notable Start date: Oct 15, 2022 to Dec 15, 2022v8
  8. Notable Start date: Jun 15, 2022 to Oct 15, 2022v7
  9. Notable Enrollment target: 4 to 40v6 Show 7 more changesShow less
    • Primary completion date: Aug 31, 2021 to May 31, 2025
    • Start date: Apr 30, 2020 to Jun 15, 2022
    • Primary endpoints: 8 to 9
    • Trial status: Active, Not Recruiting to Not Yet Recruiting
    • Interventions: Cisplatin (Drug), Hyperthermic Intraperitoneal Chemotherapy (Drug), Mitomycin (Drug) to Cisplatin (Drug), Hyperthermic Intraperitoneal Chemotherapy (Drug), Paclitaxel (Drug)
    • Eligibility criteria shortened, about 16 words
    • Study description revised
  10. Minor Trial status: Not Yet Recruiting to Active, Not Recruitingv5 Show 4 more changesShow less
    • Enrollment target: estimated 40 to confirmed 4
    • Primary completion date changed from estimate of May 31, 2025 to Aug 31, 2021
    • Start date changed from estimate of Dec 30, 2021 to Apr 30, 2020
    • Site contact updated
  11. Notable Start date: Nov 15, 2021 to Dec 30, 2021v4
  12. Notable Start date: Aug 15, 2021 to Nov 15, 2021v3
  13. Notable Start date: May 15, 2021 to Aug 15, 2021v2
  1. Minor Study First Submitted
  • 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.
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This phase II trial studies the effects of hyperthermic intraperitoneal chemotherapy (HIPEC) in treating patients with pancreatic cancer that has spread to the internal abdominal area (peritoneal metastasis). Chemotherapy drugs, such as nab-paclitaxel and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. HIPEC involves "heated" chemotherapy that is placed directly in the abdomen through laparoscopic instruments, instead of through an intravenous injection. This study may help doctors determine how safe and effective HIPEC work in treating patient with pancreatic cancer.
Trial Details
NCT Number NCT04858009
Lead Sponsor Mayo Clinic
Conditions
(from sponsor)
Metastatic Pancreatic Carcinoma, Stage IV Pancreatic Cancer AJCC v8, Metastatic Malignant Neoplasm in the Peritoneum
Related terms Pancreatic Neoplasms
Enrollment 40 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov