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
|Condition or disease||Intervention/treatment|
|Rectal Cancer Prognosis||Radiation: capecitabine and concurrent intensity modulated radiotherapy|
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 :||Observational|
|Actual Enrollment :||117 participants|
|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|
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
- overall survival [ Time Frame: 5years ]
- grade 3 or higher treatment related small bowel toxicity [ Time Frame: 5years ]
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
|General Hospital of Ningxia Medical University|
|Yinchuan, Ningxia, China, 750004|
|Principal Investigator:||Yan-Yang Wang, M.D.||General Hospital of Ningxia Medical University|