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
NCT number | NCT04334395 |
Other study ID # | MURA2016/546 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | January 1, 2017 |
Est. completion date | March 31, 2020 |
Verified date | April 2020 |
Source | Mahidol University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
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 |
Country | Name | City | State |
---|---|---|---|
Thailand | Chairat Supsamutchai | Bangkok | Bankok |
Lead Sponsor | Collaborator |
---|---|
Mahidol University |
Thailand,
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 |
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