Study on Chemotherapy Before and After Surgery for Localized Pancreatic Cancer

Sponsor: Yale University

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT02047474

Provider View

This clinical trial is exploring how well a combination of chemotherapy drugs works when given before and after surgery in patients with localized pancreatic cancer. The aim is to see if this approach can shrink the tumor before surgery and eliminate any remaining cancer cells afterward.

Patient Parameters

Program Overview

This study is testing a treatment plan for patients with localized pancreatic cancer, where chemotherapy is given both before and after surgery. The chemotherapy drugs used include leucovorin calcium, fluorouracil, irinotecan hydrochloride, and oxaliplatin. These drugs work by stopping cancer cells from growing or dividing. By giving chemotherapy before surgery, the goal is to shrink the tumor, making it easier to remove and preserving more healthy tissue. After surgery, the chemotherapy aims to destroy any leftover cancer cells.

Description

The main goal of this study is to see how long patients with resectable pancreatic cancer can live without the cancer getting worse after receiving chemotherapy before and after surgery. The chemotherapy regimen used is called mFOLFIRINOX, which includes oxaliplatin, leucovorin calcium, irinotecan hydrochloride, and fluorouracil.

Secondary goals include measuring overall survival and the response rate of the cancer to the chemotherapy given before surgery. The study will also compare the success of surgery and cancer staging with past cases that did not receive chemotherapy before surgery.

The study involves several steps:

  1. Neoadjuvant Therapy (Before Surgery): Patients receive mFOLFIRINOX chemotherapy every two weeks for six cycles, unless the cancer progresses or side effects become too severe.

  2. Surgery: Patients undergo surgery to remove the cancer 3-8 weeks after completing the initial chemotherapy.

  3. Adjuvant Therapy (After Surgery): Within 12 weeks after surgery, patients receive the same mFOLFIRINOX chemotherapy every two weeks for up to six cycles, unless the cancer progresses or side effects become too severe.

After completing the treatment, patients will have follow-up visits every two months for three years, every six months for two years, and then annually.

Eligibility Criteria

Inclusion Criteria

  • Confirmed diagnosis of pancreatic adenocarcinoma that can be surgically removed.
  • No spread of cancer outside the pancreas, as shown by scans and tests.
  • No previous treatment for pancreatic cancer.
  • No previous use of the chemotherapy drugs in this study.
  • No other active cancer within the last five years, except for certain skin or cervical cancers.
  • Good overall health with an ECOG performance status of 0 or 1.
  • Adequate organ function and blood counts.
  • Not pregnant or nursing, and women of childbearing age must have a negative pregnancy test.
  • No significant heart, lung, or neurological conditions that would interfere with the study.
  • Willingness to provide tissue samples for research purposes.

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