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CompletedNCT04096118Updated May 11, 2020

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

An observational study in Rectal Cancer, sponsored by Mahidol University. Completed at 1 site in Thailand. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-05-11.

Sponsored by Mahidol University · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
160
Ages
18 Years and older
Sex
All
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Study 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.

Read the 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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Conditions studied

  • Rectal Cancer

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Keywords

  • Rectal cancer
  • Lymph node after neoadjuvant rectal cancer
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In context

Rectal Neoplasms

1,762 studies on the registry are indexed under Rectal Neoplasms; 518 are open to participants now.

This study's enrollment of 160 is close to the median of 160 across 413 observational studies indexed under Rectal Neoplasms.

Browse Rectal Neoplasms studies →

Lead sponsor

Mahidol University is the lead sponsor of 730 studies on the registry; 118 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

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

Inclusion criteria

  • Patients with rectal cancer who underwent surgery following neoadjuvant chemoradiation.
  • Patients have tissues confirmed by Pathology
  • no metastasis before surgery

Exclusion criteria

Exclusion Criteria:

  • Distant metastasis during surgery
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Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
160 participants (actual)
Patient registry
No
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What researchers measure

Primary outcomes

  1. Survival rates

    survival rate in preoperative chemoradiation rectal cancer patients.

    Time frame: 5 year

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Study locations

1 site
  • Chairat Supsamutchai
    Bangkok, Bankok 10400, Thailand
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 11, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04096118
Lead sponsor
Mahidol University
Responsible party
Sponsor
First posted
Sep 19, 2019
Start date
Apr 1, 2018
Primary completion
Sep 30, 2019
Completion
Oct 30, 2019
Last update
May 11, 2020

Study contacts

Chairat Supsamutchai, MD
study chair · Faculty of Medicine Ramathibodi Hospital, Mahidol University
Tanet Chatmongkonwat, MD
principal investigator · of Medicine Ramathibodi Hospital, Mahidol University.

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2020. You cannot join it, but the record below documents what was studied.

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