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NCT04096118 Clinical Trial

Relationship Between Lymph Node Ratio and Survival Rate in Preoperative Chemoradiation Rectal Cancer Patients

Rectal Cancer Clinical Trial

Official title:
Relationship Between Lymph Node Ratio and Survival Rate in Preoperative Chemoradiation Rectal Cancer Patients

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04096118
Other study ID # 2017/426
Secondary ID
Status Completed
Phase
First received
Last updated
Start date April 1, 2018
Est. completion date October 30, 2019

Study information
Verified date May 2020
Source Mahidol University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Colorectal cancer is the most-common cancer of the gastrointestinal tract. The number of positive lymph nodes and total number of lymph nodes retrieved are important prognostic factors. In patients who do not receive preoperative chemoradiation, the total number of lymph nodes should be more than 12 nodes to predict accurate staging. In cases of locally-advanced rectal cancer when patients receive neoadjuvant chemoradiation it is sometimes impossible to retrieve adequate amount of lymph nodes due to the chemoradiation effect. Therefore, this study was to evaluate and predict survival rates based on positive lymph node ratio.

Description:

The primary endpoint of this study was to assess the lymph node ratio as another predictor for survival rate in preoperative chemoradiation rectal cancer patients. The other secondary objective was to determine the relationship between total harvested lymph nodes and survival rate in each stage. This is a retrospective, single-centered study, collecting data of patients from January 2011 to December 2017. Including a total of 163 patients with rectal cancer who underwent surgery following neoadjuvant chemoradiation. Using Cox regression and Kaplan-Meier survival analysis to determine whether the lymph node ratio can be used to predict the survival rate and determine the cut-off value to distinguish the prognosis of the disease.

Recruitment information / eligibility
Status Completed
Enrollment 160
Est. completion date October 30, 2019
Est. primary completion date September 30, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Patients with rectal cancer who underwent surgery following neoadjuvant chemoradiation.

- Patients have tissues confirmed by Pathology

- no metastasis before surgery

Exclusion Criteria:

- Distant metastasis during surgery

Study Design

Related Conditions & MeSH terms

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 Survival rates survival rate in preoperative chemoradiation rectal cancer patients. 5 year
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