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Completed

NCT Number: NCT03015168

Prognostic Value of Neutrophil-to-lymphocyte Ratio (NLR) on Rectal Cancer Patients

We explored the relationship between NLR and grade 3 or higher treatment related small bowel toxicity and treatment outcome of patients with rectal cancer undergoing capecitabine and concurrent intensity modulated radiotherapy (IMRT).

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

General Hospital of Ningxia Medical University

Yinchuan, Ningxia, 750004, China

About this study

Gender, age, stage of disease, and pathologic factors were retrospectively obtained from electronic patient records. Staging was determined according to the classification established by the American Joint Committee on Cancer (AJCC, 7th edition).Pelvic magnetic resonance imaging (MRI) were used for pretreatment staging. All patients enrolled in this study were treated with intensity modulated radiotherapy (IMRT) concurrent with capecitabine (1600 mg/m2/d, administered twice daily for two weeks) before or after curative resection. The mean radiation dose was 50 Gy with daily fraction of 2.0 Gy.

Acute treatment toxicity was scored according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE; version 3.0) and late toxicity was classified according to the Late Effects in Normal Tissue-Subjective, Objective, Management and Analytic (LENT-SOMA) system.

After the whole treatment procedure, all patients were subjected to a follow-up every three months for the first two years, every six months for the next three years, and every year thereafter. Physical examinations, routine blood test, serum carcinoembryonic antigen (CEA) and Cancer Antigen 19-9 (CA-199) level were checked at each follow up. Chest, abdominal CT scan and total colonoscopy were performed annually except the suspicion of tumor recurrence.

Overall survival (OS) time was defined from the date of completion of treatment to death from any cause and progression-free survival (PFS) time was defined as the time from the date of completion of therapy to the date of local recurrence or distant metastasis or death. Patient follow-up was lasted until death or the cutoff date of January 2017.Blood sampling reports from each enrolled patient were obtained within seven days before treatment. White blood cell count, neutrophil, lymphocyte and platelet counts were examined. The NLR was calculated as the absolute neutrophil count divided by the absolute lymphocyte count using baseline blood test results.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with locally advanced rectal cancer who received neoadjuvant or adjuvant chemoradiotherapy at our hospital were enrolled in this study.

Exclusion criteria

  • Patients with coexistent autoimmune diseases, infectious diseases, and lacking baseline blood test records were excluded from this study

Treatment and study plan

capecitabine and concurrent intensity modulated radiotherapy

Radiation

patients with rectal cancer undergoing capecitabine and concurrent intensity modulated radiotherapy

Primary outcomes

  1. overall survival

    Time frame: 5years

Secondary outcomes

  1. grade 3 or higher treatment related small bowel toxicity

    Time frame: 5years

Sponsors and collaborators

Lead sponsor

General Hospital of Ningxia Medical University

Other

Registry information

Official study title

Prognostic Value of Neutrophil-to-lymphocyte Ratio (NLR) on Rectal Cancer Patients Who Received Capecitabine and Concurrent Intensity Modulated Radiotherapy (IMRT)

Important dates

Study start
2012
Primary completion
2017
Study completion
2017
First posted
Jan 9, 2017
Registry last updated
Jan 9, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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