Study on Using Pre-Surgery Treatment to Improve Surgery Success for Pancreatic Cancer

Sponsor: University of Cincinnati

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT04594772

Provider View

This clinical trial is exploring whether using chemotherapy before surgery can increase the chances of successfully removing pancreatic cancer. The study uses standard treatments and evaluates their effectiveness at two different points before surgery.

Patient Parameters

Program Overview

The aim of this study is to see if giving chemotherapy before surgery can help increase the success rate of removing pancreatic cancer. The study uses standard chemotherapy treatments and evaluates their effectiveness at two different times before surgery. Researchers will also collect blood and tissue samples to help understand the treatment's impact.

Description

This study does not use any experimental drugs. All treatments follow established medical guidelines. The research focuses on evaluating the effectiveness of chemotherapy given before surgery and collecting blood and tissue samples for further analysis.

The chemotherapy treatment starts with a regimen called FOLFIRINOX, which includes the drugs 5-fluorouracil, irinotecan, and oxaliplatin. If needed, based on specific criteria, the treatment may switch to another standard regimen using gemcitabine and nab-paclitaxel. Radiation therapy might also be used before surgery, depending on the results of the final scan before the operation.

Eligibility Criteria

Inclusion Criteria

  • Must have a confirmed diagnosis of pancreatic cancer.
  • The tumor must be either removable or borderline removable, as shown by specific scans.
  • Must be 18 years or older.
  • Must be in good overall health, with a performance status score of 0 or 1.
  • Must not have received any prior treatment for the current pancreatic cancer.
  • Must have adequate organ and bone marrow function.
  • HIV-positive patients can participate if they are on effective treatment with an undetectable viral load.
  • Patients with hepatitis B or C must have the virus under control or cured.
  • Patients with a previous cancer can participate if it was treated at least two years ago and does not interfere with this study.
  • Women who can become pregnant and men who are fertile must agree to use effective birth control during the study.
  • Must be able to understand and sign a consent form.

Exclusion Criteria

  • Patients with uncontrolled health issues that would prevent them from receiving standard treatment.
  • Pregnant or breastfeeding women cannot participate.
  • Patients currently taking other experimental drugs are excluded, but those who have stopped such treatments may be eligible.
  • Patients with mental health or social issues that would prevent them from following the study requirements.
  • Patients who are unable to comply with the study requirements, as determined by the study doctor.

Get This Program In Your Inbox

Receive detailed information about this treatment opportunity to review with your healthcare provider.