Postoperative Chemotherapy in High-Grade Appendiceal Adenocarcinoma With Peritoneal Carcinomatosis

Terminated

• Conditions: Cancer
• Interventions: Drug: systemic chemotherapy

• Registration Number: NCT02420509
• Lead Sponsor: University of California, San Diego

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.

Study Timeline

• Study First Submitted: 2015-04-14
• Study First Submitted QC: 2015-04-16
• Study First Posted: 2015-04-20
• Study Start: 2015-08-27
• Primary Completion: 2017-02-09
• Study Completion: 2019-04-02
• Status Verified: 2019-10
• Last Update Submitted: 2019-10-29
• Last Update Posted: 2019-10-31

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 2

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
systemic chemotherapy after CRS/HIPEC	systemic chemotherapy	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/).

Primary Outcome Measures

Name	Time	Method
Progression-Free Survival	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 Outcome Measures

Name	Time	Method
Overall Survival	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	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	Quality of life will be measured from prior to surgery until study completion (four years)	Quality of life will be measured by the Functional Assessment of Cancer Therapy, Colorectal Symptom Index (FCSI).

Trial Locations

Locations (1)

University of California, San Diego; 🇺🇸 La Jolla, California, United States