Phase II Study to Evaluate Postoperative Chemotherapy in High-Grade Appendiceal Adenocarcinoma With Peritoneal Carcinomatosis
Overview
- Phase
- N/A
- Intervention
- systemic chemotherapy
- Conditions
- Cancer
- Sponsor
- University of California, San Diego
- Enrollment
- 2
- Locations
- 1
- Primary Endpoint
- Progression-Free Survival
- Status
- Terminated
- Last Updated
- 11 months ago
Overview
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 Description
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.
Investigators
Joel Baumgartner
Assistant Professor of Surgery
University of California, San Diego
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
systemic chemotherapy after CRS/HIPEC
Single-arm, prospective study of systemic chemotherapy after CRS/HIPEC. Subjects will be given twelve months of 5-FU or capecitabine with bevacizumab starting 4-8 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/).
Intervention: systemic chemotherapy
Outcomes
Primary Outcomes
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)
Secondary Outcomes
- Overall Survival(4 years)
- Safety and Feasibility(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 will be measured by the Functional Assessment of Cancer Therapy(Quality of life will be measured from prior to surgery until study completion (four years))