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

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ClinicalTrials.gov Identifier: NCT04096118
Recruitment Status : Recruiting
First Posted : September 19, 2019
Last Update Posted : September 19, 2019
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.

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Study Type : Observational
Estimated 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
Estimated Primary Completion Date : September 30, 2019
Estimated Study Completion Date : October 30, 2019



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



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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


Contacts
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Contact: Chairat Supsamutchai, MD (66)0851156958 pogeneral2007@hotmail.com
Contact: Tanet Chatmongkonwat, MD (66)0846122431 i_lookgolf@hotmail.com

Locations
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Thailand
Chairat Supsamutchai Recruiting
Bangkok, Bankok, Thailand, 10400
Contact: Chairat Supsamutchai, MD    022011527 ext 245    pogeneral2007@hotmail.com   
Contact: Chumpon Wilasrusmee, MD    022011527 ext 145    chumpon.wil@mahidol.ac.th   
Sponsors and Collaborators
Mahidol University
Investigators
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Study Chair: Chairat Supsamutchai, MD Faculty of Medicine Ramathibodi Hospital, Mahidol University.
Principal Investigator: Tanet Chatmongkonwat, MD of Medicine Ramathibodi Hospital, Mahidol University.

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Responsible Party: Mahidol University
ClinicalTrials.gov Identifier: NCT04096118     History of Changes
Other Study ID Numbers: 2017/426
First Posted: September 19, 2019    Key Record Dates
Last Update Posted: September 19, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
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Rectal Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Rectal Diseases
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases