Study on Heated Chemotherapy for Treating Pancreatic Cancer That Has Spread to the Abdomen

Sponsor: Mayo Clinic

Sponsor score: 60
Inactive

ClinicalTrials ID:NCT04858009

Provider View

This clinical trial is exploring the use of heated chemotherapy, known as hyperthermic intraperitoneal chemotherapy (HIPEC), to treat pancreatic cancer that has spread to the abdominal area. The study aims to determine the safety and effectiveness of this treatment method.

Patient Parameters

Program Overview

This study is investigating a treatment called hyperthermic intraperitoneal chemotherapy (HIPEC) for patients with pancreatic cancer that has spread to the abdominal area, known as peritoneal metastasis. HIPEC involves delivering heated chemotherapy drugs directly into the abdomen using special instruments, rather than through an IV. The chemotherapy drugs used in this study, nab-paclitaxel and cisplatin, work by stopping cancer cells from growing and spreading. The goal is to see if HIPEC is a safe and effective treatment option for these patients.

Description

The main goal of this study is to evaluate how well patients with pancreatic cancer that has spread to the abdomen survive and remain free of disease after receiving heated chemotherapy directly in the abdomen. The study will also look at any side effects experienced by patients undergoing this treatment.

Patients will receive HIPEC treatment with nab-paclitaxel and cisplatin for 90 minutes, as long as their disease does not worsen and they do not experience severe side effects. Some patients may receive up to five additional HIPEC treatments. Before starting the treatment, patients will undergo imaging tests like CT scans, MRIs, or PET scans.

After completing the treatment, patients will have follow-up visits every six months to monitor their health and any changes in their condition.

Eligibility Criteria

Inclusion Criteria

  • Aged between 18 and 80 years old.
  • Have a performance status score of 2 or less, indicating they are able to carry out daily activities with some limitations.
  • Have a confirmed diagnosis of pancreatic cancer.
  • Have adequate blood cell counts and kidney function as determined by specific blood tests.
  • Cancer has spread to the abdominal area, confirmed by imaging or specific tests.
  • Have completed preoperative chemotherapy with a significant reduction in cancer markers or tumor size.
  • Have a low Peritoneal Carcinomatosis Index (PCI) score, indicating limited spread of cancer in the abdomen, and a high chance of successful surgery to remove cancer.

Exclusion Criteria

  • Cancer has spread to other organs like the liver, brain, or lungs.
  • Have active infections that would prevent participation in the study.
  • Women who are pregnant or breastfeeding, or who are not using effective birth control.
  • Unable to follow study procedures or attend follow-up visits.
  • Have severe allergic reactions to the chemotherapy drugs used in the study.

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