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NCT Number: NCT04334395

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

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.

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Key information

Conditions

Stage IV Colon Cancer Colonic Diseases Colonic Neoplasms Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Chairat Supsamutchai

Bangkok, Bankok, 10400, Thailand

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

primary tumor resection group

Procedure

resection of cancer at colon

Primary outcomes

  1. Complication rate

    Time frame: 5 year

    The definition of complication defined as symptom that occurred during treatment period such as obstruction , perforation , bleeding , trenesmus.

Secondary outcomes

  1. The survival time

    Time frame: 5 year

    The survival time defined as time from diagnosis to death or last follow up period

Sponsors and collaborators

Lead sponsor

Mahidol University

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Apr 6, 2020
Registry last updated
Apr 6, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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