Surgical Outcome and Predictors of Overall Survival of Stage I-III Appendiceal Adenocarcinoma

Appendiceal Cancer Clinical Trial

Official title:

Surgical Outcome and Predictors of Overall Survival of Stage I-III Appendiceal Adenocarcinoma; a National Cancer Database Analysis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05452382
• Other study ID #: NCDBAppendix
• Status: Completed
• Start date: January 1, 2005
• Est. completion date: July 6, 2022

Study information

• Verified date: July 2022
• Source: Mansoura University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

A few studies investigated the predictors of overall survival in appendiceal adenocarcinoma. A SEER database analysis of 1404 patients with appendiceal adenocarcinoma found that older age, T4 tumors, N1-2 stage, poorly differentiated carcinoma, and distant metastasis were significantly predictive of poorer survival. Another small single-center study including 49 appendiceal cancer patients reported female gender and low-grade adenocarcinoma to be associated with increased overall survival. However, these previous analyses did not take into account some important prognosticators of survival such as patients' comorbidities and functional status, pathologic parameters such as lymphovascular invasion, and adjuvant systemic treatment. Therefore, we used the National Cancer Database (NCDB) to conduct a comprehensive analysis of the predictors of overall survival after surgical treatment of stage I-III appendiceal adenocarcinoma.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2607
• Est. completion date: July 6, 2022
• Est. primary completion date: December 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• patients with non-metastatic appendiceal adenocarcinoma who underwent surgical resection

Exclusion Criteria:

• Patients with other pathologic types of appendiceal cancer
• Patients with clinical stage IV or unknown stage
• Patients who did not undergo surgery, underwent local excision, or had unknown/non-specified surgery

Related Conditions & MeSH terms

• Adenocarcinoma
• Appendiceal Cancer
• Appendiceal Neoplasms

Intervention

Procedure:
• Partial colecctomy
Segmental resection of appendiceal adenocarcinoma including terminal ileum and cecum
• Hemicolectomy
Formal right hemicolectomy including terminal ileum, cecum, and ascending colon

Locations

Country	Name	City	State
United States	Cleveland Clinic Flroida	Weston	Florida

Sponsors (2)

Lead Sponsor	Collaborator
Mansoura University	Cleveland Clinic Florida

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival	Percent of patients who were alive at five years of follow-up	60 months
Secondary	Positive resection margins	the rate of surgical margins infiltrated by malignancy	Immediate postoperative