Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04096118
Recruitment Status : Completed
First Posted : September 19, 2019
Last Update Posted : May 11, 2020
Sponsor:
Information provided by (Responsible Party):
Mahidol University

Brief 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.

Condition or disease
Rectal Cancer

Detailed 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.

Layout table for study information
Study Type : Observational
Actual Enrollment : 160 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Relationship Between Lymph Node Ratio and Survival Rate in Preoperative Chemoradiation Rectal Cancer Patients
Actual Study Start Date : April 1, 2018
Actual Primary Completion Date : September 30, 2019
Actual Study Completion Date : October 30, 2019



Primary Outcome Measures :
  1. Survival rates [ Time Frame: 5 year ]
    survival rate in preoperative chemoradiation rectal cancer patients.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patients with rectal cancer who underwent curative surgery following neoadjuvant chemoradiation.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04096118


Locations
Layout table for location information
Thailand
Chairat Supsamutchai
Bangkok, Bankok, Thailand, 10400
Sponsors and Collaborators
Mahidol University
Investigators
Layout table for investigator information
Study Chair: Chairat Supsamutchai, MD Faculty of Medicine Ramathibodi Hospital, Mahidol University.
Principal Investigator: Tanet Chatmongkonwat, MD of Medicine Ramathibodi Hospital, Mahidol University.
Layout table for additonal information
Responsible Party: Mahidol University
ClinicalTrials.gov Identifier: NCT04096118    
Other Study ID Numbers: 2017/426
First Posted: September 19, 2019    Key Record Dates
Last Update Posted: May 11, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Mahidol University:
Rectal cancer
Lymph node after neoadjuvant rectal cancer
Additional relevant MeSH terms:
Layout table for MeSH terms
Rectal Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases