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ACTIVE NOT RECRUITING Phase 2

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

NCT04559139 · View on ClinicalTrials.gov ↗

Study Summary

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.

Interventions

  • DRUG Cisplatin
  • DRUG Gemcitabine Hydrochloride
  • PROCEDURE Lymphadenectomy
  • PROCEDURE Partial Hepatectomy

Study Locations (20)

Alaska

  • Anchorage Associates in Radiation Medicine — Anchorage
  • Anchorage Radiation Therapy Center — Anchorage
  • Alaska Breast Care and Surgery LLC — Anchorage
  • Alaska Oncology and Hematology LLC — Anchorage
  • Alaska Women's Cancer Care — Anchorage
  • Anchorage Oncology Centre — Anchorage
  • Katmai Oncology Group — Anchorage
  • Providence Alaska Medical Center — Anchorage

Arkansas

  • Mercy Hospital Fort Smith — Fort Smith
  • CHI Saint Vincent Cancer Center Hot Springs — Hot Springs
  • NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro — Jonesboro
  • CARTI Cancer Center — Little Rock
  • University of Arkansas for Medical Sciences — Little Rock

California

  • Mission Hope Medical Oncology - Arroyo Grande — Arroyo Grande
  • Providence Saint Joseph Medical Center/Disney Family Cancer Center — Burbank
  • Mercy Cancer Center - Carmichael — Carmichael
  • Mercy San Juan Medical Center — Carmichael
  • Mercy Cancer Center - Elk Grove — Elk Grove

Alabama

  • University of Alabama at Birmingham Cancer Center — Birmingham

Arizona

  • Cancer Center at Saint Joseph's — Phoenix

Trial Details

FieldValue
Enrollment Target 186 participants
Start Date 2021-02-24
Est. Completion 2029-06-30
Phase Phase 2

Sponsor

ECOG-ACRIN Cancer Research Group

52 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04559139

The ClinicalTrials.gov registry entry for NCT04559139 describes a study currently listed as active not recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 186 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is ECOG-ACRIN Cancer Research Group, which has 52 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 6 conditions, with Stage III Gallbladder Cancer AJCC v8 appearing as the primary indexed condition, and to 4 interventions — of which Cisplatin is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT04559139 reports 20 study locations spanning 5 distinct geographic areas — top geographies include Alaska, Arkansas, California. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT04559139 about?

NCT04559139 is a clinical study titled "Comparison of Chemotherapy Before and After Surgery Versus After Surgery Alone for the Treatment of Gallbladder Cancer". 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 tumo...

What is the current status of trial NCT04559139?

This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 186 participants. The study started on 2021-02-24. Estimated completion is 2029-06-30.

What conditions does trial NCT04559139 study?

This clinical trial studies the following conditions: Stage III Gallbladder Cancer AJCC v8, Stage II Gallbladder Cancer AJCC v8, Stage IIA Gallbladder Cancer AJCC v8, Stage IIB Gallbladder Cancer AJCC v8, Stage IIIA Gallbladder Cancer AJCC v8. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT04559139?

The interventions under investigation include: Cisplatin (DRUG), Gemcitabine Hydrochloride (DRUG), Lymphadenectomy (PROCEDURE), Partial Hepatectomy (PROCEDURE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT04559139?

This trial is sponsored by ECOG-ACRIN Cancer Research Group, which has 52 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT04559139 being conducted?

This trial has 20 study locations across Alabama, Alaska, Arizona, Arkansas, California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial