NCT04334395

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
135

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2017

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2017

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2020

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

April 2, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 6, 2020

Completed
Last Updated

April 6, 2020

Status Verified

April 1, 2020

Enrollment Period

3.2 years

First QC Date

April 2, 2020

Last Update Submit

April 2, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • Complication rate

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

    5 year

Secondary Outcomes (1)

  • The survival time

    5 year

Interventions

resection of cancer at colon

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • Asymptomatic stage IV colorectal cancer
  • pathological prove adenocarcinoma
  • age \>18 years
  • no primary tumor related symptom
  • ECOG performance status \<2

You may not qualify if:

  • symptomatic primary tumor such as obstruction , perforation that required surgery
  • carcinomatosis peritoneii
  • patients with secondary cancer diagnosis in 5 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chairat Supsamutchai

Bangkok, Bankok, 10400, Thailand

Location

MeSH Terms

Conditions

Colonic Neoplasms

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal Diseases

Study Officials

  • Chairat Supsamutchai, MD

    270, Rama VI road, Ratchathevi, Deapartment of Surgery, Faculty of Medicine, Ramathibodi Hospital, Mahidol University, Bangkok, Thailand, 10400

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 2, 2020

First Posted

April 6, 2020

Study Start

January 1, 2017

Primary Completion

March 1, 2020

Study Completion

March 31, 2020

Last Updated

April 6, 2020

Record last verified: 2020-04

Locations