Study on Radiation and Chemotherapy with or without Zoledronic Acid for Locally Advanced Pancreatic Cancer

Sponsor: University of Nebraska

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT03073785

Provider View

This clinical trial is testing a combination of specialized radiation therapy and chemotherapy drugs, with or without the addition of zoledronic acid, to treat pancreatic cancer that has spread to nearby tissues or lymph nodes.

Patient Parameters

Program Overview

The study aims to find out if a combination of specialized radiation therapy and chemotherapy drugs, fluorouracil or capecitabine, with or without zoledronic acid, can effectively treat pancreatic cancer that has spread to nearby tissues or lymph nodes. The radiation therapy uses higher doses over a shorter time to target the tumor, potentially causing less damage to normal tissue. Chemotherapy drugs work by stopping cancer cells from growing or spreading. Zoledronic acid may help make cancer cells more sensitive to radiation. The study will compare the effectiveness of these treatments in patients with locally advanced pancreatic cancer.

Description

The main goal of this study is to see how well a combination of specialized radiation therapy and chemotherapy drugs, with or without zoledronic acid, works in treating pancreatic cancer. The study will also look at the safety of using zoledronic acid with radiation therapy and measure how long patients live without the cancer getting worse.

Patients will be randomly assigned to one of two groups:

  • Group A: Patients will receive specialized radiation therapy over five days and chemotherapy with either fluorouracil or capecitabine for four weeks. Surgery will follow 6-8 weeks after radiation.

  • Group B: Patients will receive zoledronic acid one week before starting the same radiation and chemotherapy as Group A. Surgery will also follow 6-8 weeks after radiation.

After treatment, patients will be monitored for 30 days, then every 3 months for the first year, every 4 months for the second year, and every 6 months thereafter.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with pancreatic cancer that is locally advanced or has spread to nearby tissues, but not distant organs.
  • Tumor size must be 10 cm or smaller.
  • Patients with inoperable conditions but resectable disease are eligible.
  • Good overall health with a performance status of 60% or better.
  • Recent chemotherapy for pancreatic cancer is allowed.
  • Previous chemotherapy or radiation for other cancers over 5 years ago is allowed if there is no evidence of those cancers now.
  • All cancer must be treatable within a single radiation field.
  • Adequate blood cell counts and organ function, including:
    • Neutrophil count of at least 1500/uL.
    • Platelet count of at least 100,000/uL.
    • Serum creatinine and bilirubin levels within specified limits.
  • Must understand the nature of the disease and provide informed consent.

Exclusion Criteria

  • Allergy to zoledronic acid or related medications.
  • Uncontrolled illnesses such as active infections, heart failure, or serious heart conditions.
  • Pregnant or nursing women.
  • History of other cancers unless treated and disease-free for at least 5 years.
  • Active gastrointestinal issues like ulcers or significant bowel problems.
  • Known HIV infection or liver problems.
  • Recent use of zoledronic acid within 3 weeks before starting the study treatment.

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