Clinical Trial: Postoperative Chemotherapy in High-Grade Appendiceal Adenocarcinoma With Peritoneal Carcinomatosis

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational

Official Title: Phase II Study to Evaluate Postoperative Chemotherapy in High-Grade Appendiceal Adenocarcinoma With Peritoneal Carcinomatosis

Brief Summary:

The purpose of this study is to find out if postoperative chemotherapy in patients with high-grade appendix cancer after surgery improves outcomes.

The postoperative chemotherapy will consist of 5-FU (with leucovorin) or capecitabine with bevacizumab. These drugs are approved for use in people with colon cancer, and they are used at UCSD for some patients with appendix cancer.

The purpose of this study is to explore the safety and efficacy of the postoperative chemotherapy treatment on cancer.


Detailed Summary:

This is an observational, single-cohort, prospective study of systemic chemotherapy after CRS/HIPEC. Subjects will be given twelve months of 5-FU or capecitabine with bevacizumab starting 4-16 weeks after surgery. CTRI Biostatistics Core personnel will assist in conducting analyses using the latest version of R (R Foundation for Statistical Computing, Vienna, Austria. http://www.R-project.org/).

No therapy is included in this study. Subjects have already previously undergone surgery for their cancer. This study will observe the outcomes of the postoperative chemotherapy treatment the doctor chooses to treat the subject's cancer.


Sponsor: University of California, San Diego

Current Primary Outcome: Progression-Free Survival [ Time Frame: 4 years ]

PFS will be measured from the time of the start of postoperative chemotherapy until disease progression or death during the total study period (four years)


Original Primary Outcome:

  • Progression-Free Survival [ Time Frame: 4 years ]
    PFS will be measured from the time of the start of postoperative chemotherapy until disease progression or death during the total study period (four years)
  • Progression-Free Survival (PFS) imaging- RECIST [ Time Frame: 4 years ]
    Progression will be assessed by imaging, per the Response Evaluation Criteria in Solid Tumors (RECIST) or by biochemical markers in those patients without radiographic evidence of progression, per standard tumor marker progression criteria.
  • Tumor assessment [ Time Frame: 4 year ]
    CT chest, abdomen, pelvis will be obtained 4-6 weeks postoperatively (baseline), then every 3 months for 1 year during treatment, then every 3 months for 1 year, then every 6 months for another year, then annually for 1 year.
  • Median PFS [ Time Frame: one year ]
    Median PFS will be analyzed by the Kaplan-Meier method and compared to historic controls (at UCSD and from other institutions).


Current Secondary Outcome:

  • Overall Survival [ Time Frame: 4 years ]
    OS will be measured from the time of the start of postoperative chemotherapy until death during the total study period (four years)
  • Safety and Feasibility [ Time Frame: Safety and feasibility of the chemotherapy regimen will be measured from the time of the start of postoperative chemotherapy until completion of chemotherapy (one year) ]
  • Quality of Life [ Time Frame: Quality of life will be measured from prior to surgery until study completion (four years) ]


Original Secondary Outcome:

Information By: University of California, San Diego

Dates:
Date Received: April 14, 2015
Date Started: April 2015
Date Completion: December 2020
Last Updated: May 11, 2016
Last Verified: May 2016