Clinical trial NCT05673343: The Prognostic Impact Of The Neutrophil To Lymphocyte Ratio In Patients With Locally Advanced Rectal Cancer
Official title: The Prognostic Impact Of The Neutrophil To Lymphocyte Ratio In Patients With Locally Advanced Rectal Cancer
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: the Prognostic Value of Pre-treatment NLR in Patients With Locally Advenced Rectal Cancer and Post-treatment
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2023-01-06
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

Brief summary: 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: 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

Eligibility criteria: 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

Primary outcomes:
measure: disease free-survival
timeFrame: 2-5 yrs
Secondary outcomes:
measure: overall survival (OS
timeFrame: 2-5 years
Other outcomes:
Locations:
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.