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

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ClinicalTrials.gov Identifier: NCT03015168
Recruitment Status : Completed
First Posted : January 9, 2017
Last Update Posted : January 9, 2017
Sponsor:
Information provided by (Responsible Party):
General Hospital of Ningxia Medical University

Brief Summary:
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).

Condition or disease Intervention/treatment
Rectal Cancer Prognosis Radiation: capecitabine and concurrent intensity modulated radiotherapy

Detailed Description:

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.

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Study Type : Observational
Actual Enrollment : 117 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Prognostic Value of Neutrophil-to-lymphocyte Ratio (NLR) on Rectal Cancer Patients Who Received Capecitabine and Concurrent Intensity Modulated Radiotherapy (IMRT)
Study Start Date : January 2012
Actual Primary Completion Date : January 2017
Actual Study Completion Date : January 2017

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Observational Group
Patients with rectal cancer undergoing capecitabine and concurrent intensity modulated radiotherapy
Radiation: capecitabine and concurrent intensity modulated radiotherapy
patients with rectal cancer undergoing capecitabine and concurrent intensity modulated radiotherapy




Primary Outcome Measures :
  1. overall survival [ Time Frame: 5years ]

Secondary Outcome Measures :
  1. grade 3 or higher treatment related small bowel toxicity [ Time Frame: 5years ]


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
patients with rectal cancer undergoing capecitabine and concurrent intensity modulated radiotherapy
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03015168


Locations
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China, Ningxia
General Hospital of Ningxia Medical University
Yinchuan, Ningxia, China, 750004
Sponsors and Collaborators
General Hospital of Ningxia Medical University
Investigators
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Principal Investigator: Yan-Yang Wang, M.D. General Hospital of Ningxia Medical University
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Responsible Party: General Hospital of Ningxia Medical University
ClinicalTrials.gov Identifier: NCT03015168    
Other Study ID Numbers: Radiation Oncology 201602
First Posted: January 9, 2017    Key Record Dates
Last Update Posted: January 9, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Rectal Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases
Capecitabine
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents