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

NCT04559139 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 186

Last updated 2026-05-01

No results posted yet for this 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.

Conditions

  • 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

Interventions

PROCEDURE

Partial Hepatectomy

Undergo partial hepatectomy

DRUG

Cisplatin

Given IV

DRUG

Gemcitabine Hydrochloride

Given IV

PROCEDURE

Lymphadenectomy

Undergo portal lymphadenectomy

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • ECOG-ACRIN Cancer Research Group

    lead NETWORK

Principal Investigators

  • Shishir K Maithel · ECOG-ACRIN Cancer Research Group

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-02-24
Primary Completion
2028-07-01
Completion
2029-06-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04559139 on ClinicalTrials.gov