Clinical trial · Observational
The Prognostic Impact Of The Neutrophil To Lymphocyte Ratio In Patients With Locally Advanced Rectal Cancer
NCT05673343CI-TRIAL-00063048unknownClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| the Prognostic Value of Pre-treatment NLR in Patients With Locally Advenced Rectal Cancer and Post-treatment | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (1)
- label
- Complete blood count
- description
- 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.
Primary outcomes (1)
- measure
- disease free-survival
- timeFrame
- 2-5 yrs
- description
- defined as the time from the day of disease diagnosis until the day of disease failure.
Secondary outcomes (1)
- measure
- overall survival (OS
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 90 Years
Show eligibility criteria text
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
References
Publications (5)
- BACKGROUNDYang 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. PMID 35597954
- BACKGROUNDNagasaki 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. PMID 26544755
- BACKGROUNDSun 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. PMID 32020327
- BACKGROUNDCha 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. PMID 30901357
- RESULTToiyama 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. PMID 25692418