Comparing Chemotherapy Before and After Surgery to After Surgery Alone for Gallbladder Cancer Treatment

Sponsor: ECOG-ACRIN Cancer Research Group

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT04559139

Provider View

This clinical trial is exploring whether adding chemotherapy before surgery, in addition to after surgery, is more effective than the usual approach of only giving chemotherapy after surgery for patients with stage II-III gallbladder cancer.

Patient Parameters

Program Overview

This study is investigating if giving chemotherapy drugs, gemcitabine and cisplatin, before and after surgery can better control stage II-III gallbladder cancer compared to giving these drugs only after surgery. Chemotherapy works by stopping cancer cells from growing and spreading. Administering it before surgery might shrink the tumor, making surgery easier and more effective. The study aims to find out if this approach can delay the cancer's return and improve patients' survival rates.

Description

The main goal of this study is to see if patients who receive chemotherapy both before and after surgery live longer than those who only receive it after surgery. The study will also look at whether chemotherapy before surgery reduces the amount of cancer left at the time of surgery and if it affects how easily the cancer can be removed.

Participants are divided into two groups:

  • Group 1: Patients have surgery to remove part of the liver and nearby lymph nodes, followed by chemotherapy with gemcitabine and cisplatin every 21 days for up to 8 cycles, unless the cancer progresses or side effects become too severe.

  • Group 2: Patients receive chemotherapy with gemcitabine and cisplatin every 21 days for 4 cycles before surgery. If the cancer hasn't spread, they undergo surgery similar to Group 1. After successful surgery, they resume chemotherapy for up to 4 more cycles.

After treatment, patients are monitored every 3 months for 2 years, then every 6 months for another year, or until the cancer returns, for up to 5 years.

Eligibility Criteria

Inclusion Criteria

  • Must be in good general health with an ECOG performance status of 0-1.
  • Must have stage II or III gallbladder cancer found unexpectedly during or after gallbladder removal surgery.
  • Must have had gallbladder removal surgery within the last 12 weeks.
  • Must be able to understand and agree to the study by signing a consent form.
  • Must have adequate blood cell counts and organ function based on recent tests.
  • HIV-positive patients can participate if their viral load is undetectable.
  • Patients with controlled hepatitis B or cured hepatitis C can participate.
  • Patients with other cancers that do not interfere with this study can participate.
  • Patients with heart disease must have a low risk of heart problems.

Exclusion Criteria

  • Must not have cancer that has spread to other parts of the body or cannot be surgically removed, based on recent imaging tests.
  • Women must not be pregnant or breastfeeding and must use effective birth control during the study.
  • Men and women of childbearing potential must agree to use birth control or abstain from sex during the study.

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