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Perioperative Therapy Preoperative Chemotherapy Versus Chemoradiotherapy in Locally Advanced Gall Bladder Cancers

Study acronym: POLCAGB
StatusActive, Not Recruiting
PhasePhase 2/3
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated March 13, 2025 (before its estimated September 10, 2025 completion). Its status may not reflect the trial's current state.

Record History

  1. Trial status: Recruiting to Active, Not Recruiting Enrollment target: estimated 314 to confirmed 124 · Site details revisedv4 Show 2 more changesShow less
    • Enrollment target: estimated 314 to confirmed 124
    • Site details revised
  2. Primary completion date: Aug 2021 to Sep 10, 2025 Completion date: Aug 2022 to Sep 10, 2027 · Start date: Oct 2016 to Sep 6, 2016v3 Show 2 more changesShow less
    • Completion date: Aug 2022 to Sep 10, 2027
    • Start date: Oct 2016 to Sep 6, 2016
  3. Trial status: Not Yet Recruiting to Recruiting Start date: Aug 2016 to Oct 2016 · Secondary endpoints revised (4) · Site details revisedv2 Show 3 more changesShow less
    • Start date: Aug 2016 to Oct 2016
    • Secondary endpoints revised (4)
    • Site details revised

    See this version in full on ClinicalTrials.gov ↗

  4. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Locally advanced Gall bladders cancers not amenable for curative resection are often treated with chemotherapy alone which is the current standard of care. Randomized trials have shown survival benefit with combination chemotherapy in gallbladder cancers. Gallbladder cancer is not common western world and thus there is lack of evidence regarding the impact of neoadjuvant or concurrent chemo-radiation in this cancer.Use of neoadjuvant treatment with chemotherapy alone or chemoradiotherapy has shown to downsize these tumors to safely undergo R0 resection in few published studies. Also if the patients develop distant metastasis during this neoadjuvant therapy they can be spared of unnecessary surgery. In a pilot study of 28 patients by Engineer et al conducted at Tata Memorial centre treated with neoadjuvant concurrent chemoradiation the investigators could achieve R0 resectability rate 0f 47% with a median overall survival (OAS) and progression free survival (PFS) of 35 and 20 months for the patients undergoing R0 resection. In this study the investigators intend to compare the effects of using neoadjuvant chemotherapy alone vs. neoadjuvant chemoradiation and chemotherapy for locally advanced gall bladder cancers in terms of down staging and overall survival.
Trial Details
NCT Number NCT02867865
Lead Sponsor Tata Memorial Hospital
Conditions Gall Bladder Cancers
Enrollment 124 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov