Study on Using Gemcitabine and Capecitabine Chemotherapy After Surgery for Pancreatic Cancer

Sponsor: Rutgers, The State University of New Jersey

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT05415917

Provider View

This clinical trial is exploring whether adding more chemotherapy after surgery can improve outcomes for patients with pancreatic cancer who have already received chemotherapy before surgery.

Patient Parameters

Program Overview

The aim of this study is to find out if giving additional chemotherapy with gemcitabine and capecitabine after surgery can help patients with pancreatic cancer live longer without the disease coming back, compared to just having chemotherapy before surgery. The study will also look at how safe and tolerable this treatment is, and how it affects patients' quality of life.

Description

This study is comparing two treatment approaches for pancreatic cancer. The usual approach involves chemotherapy followed by surgery. In this study, researchers want to see if adding more chemotherapy after surgery is better, the same, or worse than the usual approach. The goal is to see if this new approach can help patients live longer.

Participants will be divided into two groups. One group will receive additional chemotherapy with gemcitabine and capecitabine every 28 days for 6 cycles after surgery. The other group will be observed with standard care. Participants will undergo regular imaging tests, like CT scans, and lab tests to check for any return of the cancer. The study will last for about 30 months.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with pancreatic ductal adenocarcinoma confirmed by lab tests.
  • Received chemotherapy (for at least three months) before surgery, with or without radiation, followed by successful surgery.
  • In good general health, with a performance status score between 0 and 2.
  • At least 18 years old.
  • Have adequate blood cell counts and organ function, including:
    • Neutrophil count of at least 1000 cells/μL.
    • Hemoglobin level of at least 8 g/dL.
    • Platelet count over 75,000/μL.
    • Normal kidney function or creatinine clearance of at least 30 mL/min.
    • Bilirubin level within normal limits.
    • Liver enzymes within specified limits, unless liver metastases are present.
  • Agree to use effective birth control during the study.
  • Able to understand the study and provide written consent.
  • Willing to follow the study schedule and procedures.

Exclusion Criteria

  • Currently taking any investigational drugs.
  • Have untreated cancer spread to the brain.
  • Have cancer that has spread to other parts of the body or fluid buildup in the abdomen.
  • Have significant nerve damage.
  • Have had another active cancer in the past 3 years that could affect treatment.
  • Have uncontrolled health issues, like severe infections or heart problems.
  • Have had major surgery in the past 4 weeks.
  • Have allergies to any study drugs.
  • Have any medical or psychiatric conditions that would prevent full participation.
  • Are pregnant.
  • Have severe liver problems.
  • Have known absorption issues.

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