Clinical Trial: Antibiotic Treatment and Long-term Outcomes of Patients With Pseudomyxoma Peritonei of Appendiceal Origin

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Clinical Trial to Define the Effect of Perioperative H. Pylori Eradication With Antibiotic Treatment on the Long Term Outcomes of Patients With Pseudomyxoma Peritonei of Appendiceal Origin Undergoing

Brief Summary: The purpose of this study is to determine the impact of antibiotic therapy on the disease progression and overall survival of patients with Pseudomyxoma Peritonei (PMP).

Detailed Summary: Single center, open label, historical controlled, phase II study that proposes two courses of standard H. Pylori eradication antibiotic therapy can suppress carcinogenesis and improve the long-term outcomes of patients with PMP. The first course of antibiotics (PrevPac) will be administered before cytoreductive surgery and HIPEC and the second course afterwards. The historical control group will consist of all PMP patients from Mercy Medical Center's Tumor Registry who did not receive perioperative antibiotic treatment. Long-term statistical outcomes will be calculated using the Kaplan-Meier method and Cox proportional hazard ratio to compare pertinent variable. 80 subjects to be enrolled over 2 years, with a 5 year follow-up period.
Sponsor: Mercy Medical Center

Current Primary Outcome:

  • Overall survival measured by survival rates [ Time Frame: 1 year after diagnosis ]
  • Overall survival measured by survival rates [ Time Frame: 3 years after diagnosis ]
  • Overall survival measured by survival rates [ Time Frame: 5 years after diagnosis ]


Original Primary Outcome: Same as current

Current Secondary Outcome: Progression-free survival measured by no evidence of disease progression, i.e. tumor markers within normal limits, no radiographical evidence of disease [ Time Frame: at 1, 3, and 5 years after surgery ]

Original Secondary Outcome: Same as current

Information By: Mercy Medical Center

Dates:
Date Received: January 19, 2015
Date Started: January 2015
Date Completion: December 2021
Last Updated: February 16, 2017
Last Verified: February 2017