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

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

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.

Study Overview

• Status: Completed
• Conditions: Stage IV Colon Cancer
• Intervention / Treatment: Procedure: primary tumor resection group

Detailed 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.

• Study Type: Observational
• Enrollment (Actual): 135

Contacts and Locations

Study Locations

• Thailand
  • Bankok
    • Bangkok, Bankok, Thailand, 10400
      • Chairat Supsamutchai

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Medical records of stage IV colorectal cancer with unresectable distant metastasis received treatment in Ramathibodi hospital between 1 September 2006 - 31 August 2016.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complication rate	The definition of complication defined as symptom that occurred during treatment period such as obstruction , perforation , bleeding , trenesmus.	5 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The survival time	The survival time defined as time from diagnosis to death or last follow up period	5 year

Collaborators and Investigators

• Sponsor: Mahidol University
• Investigators: Study Chair: Chairat Supsamutchai, MD, 270, Rama VI road, Ratchathevi, Deapartment of Surgery, Faculty of Medicine, Ramathibodi Hospital, Mahidol University, Bangkok, Thailand, 10400

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2017
• Primary Completion (Actual): March 1, 2020
• Study Completion (Actual): March 31, 2020

Study Registration Dates

• First Submitted: April 2, 2020
• First Submitted That Met QC Criteria: April 2, 2020
• First Posted (Actual): April 6, 2020

Study Record Updates

• Last Update Posted (Actual): April 6, 2020
• Last Update Submitted That Met QC Criteria: April 2, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms
• Other Study ID Numbers: MURA2016/546

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No