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Hypofractionated Stereotactic Body Radiation & Fluorouracil or Capecitabine for Locally Advanced Pancreatic Cancer

StatusActive, Not Recruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Minor Trial status: Recruiting to Active, Not Recruiting Enrollment target: estimated 44 to confirmed 46 · Eligibility criteria revised · Site details revisedv14 Show 3 more changesShow less
    • Enrollment target: estimated 44 to confirmed 46
    • Eligibility criteria revised
    • Site details revised

    See this version in full on ClinicalTrials.gov ↗

  2. Notable Primary endpoints revised (3) Eligibility criteria shortened, about 101 words · Secondary endpoints revised (8) · Study description expanded, about 64 wordsv13 Show 3 more changesShow less
    • Eligibility criteria shortened, about 101 words
    • Secondary endpoints revised (8)
    • Study description expanded, about 64 words

    See this version in full on ClinicalTrials.gov ↗

  3. Minor Re-verified, no change to tracked fieldsv12
  4. Notable Primary and study completion dates: Dec 2024 to Dec 2027v11
  5. Notable Lead sponsor: Chi Lin, MD, PhD to University of Nebraska Site contact updated · Study title shortened, about 9 wordsv10 Show 2 more changesShow less
    • Site contact updated
    • Study title shortened, about 9 words

    See this version in full on ClinicalTrials.gov ↗

Show 8 earlier versionsHide 8 earlier versions
  1. Minor Re-verified, no change to tracked fieldsv9
  2. Notable Primary and study completion dates: Dec 2022 to Dec 2024v8
  3. Notable Primary completion date: Dec 2021 to Dec 2022 Completion date: May 2022 to Dec 2022v7 Show 1 more changeShow less
    • Completion date: May 2022 to Dec 2022
  4. Notable Lead sponsor: Chi Lin, MD to Chi Lin, MD, PhDv6
  5. Notable Primary completion date: May 2020 to Dec 2021 Completion date: May 2021 to May 2022v5 Show 1 more changeShow less
    • Completion date: May 2021 to May 2022
  6. Minor Secondary endpoints: details revised at 2 of 8 entriesv4
  7. Notable Primary completion date: Sep 16, 2019 to May 2020 Enrollment target: 40 to 44 · Completion date: Sep 16, 2020 to May 2021 · Secondary endpoints: 7 to 8 · 1 morev3 Show 4 more changesShow less
    • Enrollment target: 40 to 44
    • Completion date: Sep 16, 2020 to May 2021
    • Secondary endpoints: 7 to 8
    • Eligibility criteria expanded, about 3 words

    See this version in full on ClinicalTrials.gov ↗

  8. Minor Primary completion date: Sep 2019 to Sep 16, 2019 Completion date: Sep 2020 to Sep 16, 2020 · Start date: Jan 25, 2017 to Sep 16, 2016 · Eligibility criteria shortened, about 66 words · 2 morev2 Show 5 more changesShow less
    • Completion date: Sep 2020 to Sep 16, 2020
    • Start date: Jan 25, 2017 to Sep 16, 2016
    • Eligibility criteria shortened, about 66 words
    • Secondary endpoints: 11 to 7
    • Study description expanded, about 2 words

    See this version in full on ClinicalTrials.gov ↗

  1. Minor 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.
Pancreatic cancer, most commonly adenocarcinoma, is the fourth leading cause of cancer death in the United States. The mainstay of management centers on surgical resection (if resectable) and although low (15% to 20%), resectability rates are associated with dismal survival. An estimated 80% to 85% of the patients recur after surgical resection, leading to a median survival of 20 to 24 months and potentially even less depending on lymph nodal involvement or positive margins. The rationale for utilizing neoadjuvant therapy, commonly fluoropyrimidine-based or gemcitabine based chemotherapy or Chemoradiotherapy (CRT), involves possibly down staging borderline resectable and unresectable patients, potentially making them resectable candidates. This randomized phase II trial will study how well hypofractionated stereotactic body radiation therapy (SBRT) and fluorouracil or capecitabine with or without zoledronic acid work in treating participants with pancreatic cancer that has spread to nearby tissue or lymph nodes. Hypofractionated stereotactic body radiation therapy is a specialized radiation therapy that sends higher doses of x-rays over a shorter period of time directly to the tumor using smaller doses over several days which may cause less damage to normal tissue. Drugs used in chemotherapy, such as fluorouracil and capecitabine, 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. Zoledronic acid is used in cancer patients to reduce cancer symptoms and may make tumor cells more sensitive to radiation. Giving hypofractionated stereotactic body radiation therapy and fluorouracil or capecitabine with or without zoledronic acid may work better in treating pancreatic cancer.
Trial Details
NCT Number NCT03073785
Lead Sponsor University of Nebraska
Collaborators: National Cancer Institute (NCI)
Conditions Pancreatic Adenocarcinoma, Recurrent Pancreatic Carcinoma, Stage I Pancreatic Cancer AJCC v6 and v7, Stage IA Pancreatic Cancer AJCC v6 and v7, Stage IB Pancreatic Cancer AJCC v6 and v7, Stage II Pancreatic Cancer AJCC v6 and v7, Stage IIA Pancreatic Cancer AJCC v6 and v7, Stage IIB Pancreatic Cancer AJCC v6 and v7 +2 more
Enrollment 46 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov