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Comparison of Chemotherapy Before and After Surgery Versus After Surgery Alone for the Treatment of Gallbladder Cancer

StatusActive, Not Recruiting
PhasePhase 2/3
Started
View on ClinicalTrials.gov ↗

Record History

  1. 3 versions Re-verified since Jun 16, 2026, no change to tracked fieldsv22-v24
  2. Site details revised at 1 of 367 sitesv21
  3. Primary completion date: Jun 30, 2029 to Jul 1, 2028
    • Site details revised at 1 of 367 sites
    v20
  4. 7 versions Re-verified since Aug 14, 2025, no change to tracked fieldsv13-v19
  5. Trial status: Recruiting to Active, Not Recruiting
    • Site details revised at 367 of 367 sites
    v12
Show 10 earlier versionsHide 10 earlier versions
  1. Study sites: 361 to 367v11
  2. Site details revised at 3 of 361 sitesv10
  3. Study sites: 329 to 361v9
  4. Re-verified, no change to tracked fieldsv8
  5. Start date: Dec 22, 2020 to Feb 24, 2021v7
  6. Study sites: 1 to 329v6
  7. Primary and study completion dates: Sep 30, 2023 to Jun 30, 2029v5
  8. 2 versions Re-verified since Dec 29, 2021, no change to tracked fieldsv3-v4
  9. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Start date changed from estimate of Jul 20, 2021 to Dec 22, 2020
    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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
This phase II/III trial compares the effect of adding chemotherapy before and after surgery versus after surgery alone (usual treatment) in treating patients with stage II-III gallbladder cancer. Chemotherapy drugs, such as gemcitabine 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. Giving chemotherapy before surgery may make the tumor smaller; therefore, may reduce the extent of surgery. Additionally, it may make it easier for the surgeon to distinguish between normal and cancerous tissue. Giving chemotherapy after surgery may kill any remaining tumor cells. This study will determine whether giving chemotherapy before surgery increases the length of time before the cancer may return and whether it will increase a patient's life span compared to the usual approach.
Trial Details
NCT Number NCT04559139
Lead Sponsor ECOG-ACRIN Cancer Research Group
Collaborators: National Cancer Institute (NCI)
Conditions
(from sponsor)		 Stage II Gallbladder Cancer AJCC v8, Stage IIA Gallbladder Cancer AJCC v8, Stage IIB Gallbladder Cancer AJCC v8, Stage III Gallbladder Cancer AJCC v8, Stage IIIA Gallbladder Cancer AJCC v8, Stage IIIB Gallbladder Cancer AJCC v8
Related terms Gallbladder Neoplasms
Enrollment 186 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov