- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03015168
Prognostic Value of Neutrophil-to-lymphocyte Ratio (NLR) on Rectal Cancer Patients
Prognostic Value of Neutrophil-to-lymphocyte Ratio (NLR) on Rectal Cancer Patients Who Received Capecitabine and Concurrent Intensity Modulated Radiotherapy (IMRT)
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Ningxia
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Yinchuan, Ningxia, China, 750004
- General Hospital of Ningxia Medical University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Observational Group
Patients with rectal cancer undergoing capecitabine and concurrent intensity modulated radiotherapy
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patients with rectal cancer undergoing capecitabine and concurrent intensity modulated radiotherapy
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
overall survival
Time Frame: 5years
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5years
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
grade 3 or higher treatment related small bowel toxicity
Time Frame: 5years
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5years
|
Collaborators and Investigators
Investigators
- Principal Investigator: Yan-Yang Wang, M.D., General Hospital of Ningxia Medical University
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms
- Neoplasms by Site
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Gastrointestinal Diseases
- Intestinal Diseases
- Intestinal Neoplasms
- Rectal Diseases
- Colorectal Neoplasms
- Rectal Neoplasms
- Molecular Mechanisms of Pharmacological Action
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Capecitabine
Other Study ID Numbers
- Radiation Oncology 201602
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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-
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