The Prognostic Impact Of The Neutrophil To Lymphocyte Ratio In Patients With Locally Advanced Rectal Cancer

January 4, 2023 updated by: Shymaa tarek shafea, Assiut University
In this study, we aim to investigate the prognostic value of pre-treatment NLR in patients with locally advenced rectal cancer and post-treatment

Study Overview

Status

Not yet recruiting

Conditions

Detailed Description

Colorectal cancer (CRC) is the third most common malignancy and the second leading cause of cancer-related death worldwide.[1] Rectal cancer accounts for 30% to 35% of CRCs[2], Between 5% and 10% of patients with rectal cancer present with locally advanced rectal cancer (LARC),[3] Useful and practical prognostic biomarkers obtained before treatment are anticipated to predict the outcome after main treatment. Such biomarkers will help in planning strategies for adjustment of postoperative adjuvant therapy.[4]

Inflammation-induced markers play an important role in tumorigenesis and tumor progression. More evidences had reported systemic inflammation-based biomarkers could be used to predict tumor behavior.[4] Two convenient and economic measures of systemic inflammation, neutrophil-to-lymphocyte ratio (NLR) and platelet-to-lymphocyte ratio (PLR), that reflect the interaction between inflammation and host immune status, making them potential prognostic factors for various types of cancers. Increased NLR has been advocated to be an independent prognostic factor for poor survival outcomes in pancreatic cancer, CRC, and gastric cancer [5-6].

In this study, we aim to investigate the prognostic value of pre-treatment NLR in patients with locally advenced rectal cancer and post-treatment

Study Type

Observational

Enrollment (Anticipated)

100

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients aged 18-year-old or more 2-Histopathologically proved to be rectal carcinoma. 3- locally advanced stage II and stage III according to AJCC TNM staging 8th edition 4- fit for concurrent chemoradiation therapy (CCRT) with adequate organ function.

5- Performance status 0-1 according to ECOG PS

Description

Inclusion Criteria:

- Patients aged 18-year-old or more 2-Histopathologically proved to be rectal carcinoma. 3- locally advanced stage II and stage III according to AJCC TNM staging 8th edition 4- fit for concurrent chemoradiation therapy (CCRT) with adequate organ function.

5- Performance status 0-1 according to ECOG PS

Exclusion Criteria:

  • 1- metastatic disease 2- Younger than 18 year old 3-Any other malignancy 4-There is contraindication for CCRT

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Complete blood count

Complete blood count with differential should be done within 2 weeks before starting CCRT. We will calculate NLR as total neutrophilic count divided by total lymphocytic count for each patient before starting the treatment.

Two protocols of the treatment: first is by starting with CCRT then surgery (Total Neoadjuvant Therapy), second is CCRT then surgery then continue chemotherapy: FOLFOX , Xeloda or CAPOX.

Radiotherapy dose: long course radiation therapy at the dose of 45 to 50 Gray (Gy) in 25 to 28 fractions to the pelvis by NCCN recommendation. Short-course radiation therapy (25 Gy in 5 fractions).

Patients should be kept on follow up after complete their treatment every three months till disease progression occur, death of the patient or at least 12 months of follow up.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
disease free-survival
Time Frame: 2-5 yrs
defined as the time from the day of disease diagnosis until the day of disease failure.
2-5 yrs

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
overall survival (OS
Time Frame: 2-5 years
defined as the time from the day of disease diagnosis until the date of death.
2-5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

January 4, 2023

Primary Completion (Anticipated)

January 1, 2024

Study Completion (Anticipated)

March 1, 2024

Study Registration Dates

First Submitted

January 4, 2023

First Submitted That Met QC Criteria

January 4, 2023

First Posted (Estimate)

January 6, 2023

Study Record Updates

Last Update Posted (Estimate)

January 6, 2023

Last Update Submitted That Met QC Criteria

January 4, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Locally advanced rectal cancer

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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