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

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

Detailed Description
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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

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

Conditions
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the Prognostic Value of Pre-treatment NLR in Patients With Locally Advenced Rectal Cancer and Post-treatment

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Complete blood count<br>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?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| disease free-survival | 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 | defined as the time from the day of disease diagnosis until the date of death. | 2-5 years |