A Retrospective Cohort Study Outcome of Treatment in Asymptomatic Stage 4 Colorectal Cancer

Stage IV Colon Cancer Clinical Trial

Official title:

A Retrospective Cohort Study Outcome of Treatment in Asymptomatic Stage 4 Colorectal Cancer : Primary Tumor Resection vs. No Primary Tumor Resection

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04334395
• Other study ID #: MURA2016/546
• Status: Completed
• Start date: January 1, 2017
• Est. completion date: March 31, 2020

Study information

• Verified date: April 2020
• Source: Mahidol University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

In asymptomatic Stage 4 colorectal cancer, the treatment varies between many hospitals and countries. Some studies found that primary tumor resection had better survival rates and a lower risk of mortality. But many studies found significant benefits in survival in sub groups of the population such as age less than 70 years, WHO performance status <2, no extra-hepatic metastasis, liver tumor burden <50%. However some studies showed no survival benefits in primary tumor resection. So this study will focus on survival, adverse events, complications in primary tumor resection and no primary tumor resection in asymptomatic Stage 4 colorectal cancer.

Description:

The retrospective study of patients in asymptomatic Stage 4 colorectal cancer received treatment at Ramathibodi Hospital and excluded symptomatic primary tumors such as obstruction, perforation that required surgery, carcinomatosis peritoneii, and patients with secondary cancer diagnosis in the past 5 years.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 135
• Est. completion date: March 31, 2020
• Est. primary completion date: March 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Asymptomatic stage IV colorectal cancer

• pathological prove adenocarcinoma

• age >18 years

• no primary tumor related symptom

• ECOG performance status <2

Exclusion Criteria:

• symptomatic primary tumor such as obstruction , perforation that required surgery

• carcinomatosis peritoneii

• patients with secondary cancer diagnosis in 5 years

Related Conditions & MeSH terms

• Colorectal Neoplasms
• Stage IV Colon Cancer

Intervention

Procedure:
• primary tumor resection group
resection of cancer at colon

Locations

Country	Name	City	State
Thailand	Chairat Supsamutchai	Bangkok	Bankok

Sponsors (1)

Lead Sponsor	Collaborator
Mahidol University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Complication rate	The definition of complication defined as symptom that occurred during treatment period such as obstruction , perforation , bleeding , trenesmus.	5 year
Secondary	The survival time	The survival time defined as time from diagnosis to death or last follow up period	5 year