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

NCT ID: NCT05673343

Last Updated: 2023-01-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-01-04

Study Completion Date

2024-03-01

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

Conditions

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

No interventions assigned to this group

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Shymaa tarek shafea

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

Responsibility Role PRINCIPAL_INVESTIGATOR

References

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Yang G, Chang JS, Choi JE, Baek ES, Kim SS, Byun HK, Cho Y, Koom WS, Yang SY, Min BS, Shin SJ. Association of neutrophil-to-lymphocyte ratio, radiotherapy fractionation/technique, and risk of development of distant metastasis among patients with locally advanced rectal cancer. Radiat Oncol. 2022 May 21;17(1):100. doi: 10.1186/s13014-022-02065-8.

Reference Type BACKGROUND
PMID: 35597954 (View on PubMed)

Nagasaki T, Akiyoshi T, Fujimoto Y, Konishi T, Nagayama S, Fukunaga Y, Ueno M. Prognostic Impact of Neutrophil-to-Lymphocyte Ratio in Patients with Advanced Low Rectal Cancer Treated with Preoperative Chemoradiotherapy. Dig Surg. 2015;32(6):496-503. doi: 10.1159/000441396. Epub 2015 Nov 7.

Reference Type BACKGROUND
PMID: 26544755 (View on PubMed)

Sun Y, Zhang Y, Huang Z, Lin H, Lu X, Huang Y, Chi P. Combination of Preoperative Plasma Fibrinogen and Neutrophil-to-Lymphocyte Ratio (the F-NLR Score) as a Prognostic Marker of Locally Advanced Rectal Cancer Following Preoperative Chemoradiotherapy. World J Surg. 2020 Jun;44(6):1975-1984. doi: 10.1007/s00268-020-05407-3.

Reference Type BACKGROUND
PMID: 32020327 (View on PubMed)

Cha YJ, Park EJ, Baik SH, Lee KY, Kang J. Prognostic impact of persistent lower neutrophil-to-lymphocyte ratio during preoperative chemoradiotherapy in locally advanced rectal cancer patients: A propensity score matching analysis. PLoS One. 2019 Mar 22;14(3):e0214415. doi: 10.1371/journal.pone.0214415. eCollection 2019.

Reference Type BACKGROUND
PMID: 30901357 (View on PubMed)

Toiyama Y, Inoue Y, Kawamura M, Kawamoto A, Okugawa Y, Hiro J, Saigusa S, Tanaka K, Mohri Y, Kusunoki M. Elevated platelet count as predictor of recurrence in rectal cancer patients undergoing preoperative chemoradiotherapy followed by surgery. Int Surg. 2015 Feb;100(2):199-207. doi: 10.9738/INTSURG-D-13-00178.1.

Reference Type RESULT
PMID: 25692418 (View on PubMed)

Other Identifiers

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Locally advanced rectal cancer

Identifier Type: -

Identifier Source: org_study_id

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