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

Rectal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03015168
• Other study ID #: Radiation Oncology 201602
• Status: Completed
• Phase: N/A
• First received: January 6, 2017
• Last updated: January 6, 2017
• Start date: January 2012
• Est. completion date: January 2017

Study information

• Verified date: January 2017
• Source: General Hospital of Ningxia Medical University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Health and Family Planning Commission of Ningxia Hui Autonomous Region
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 117
• Est. completion date: January 2017
• Est. primary completion date: January 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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 Design

Observational Model: Case-Only, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Prognosis
• Rectal Cancer
• Rectal Neoplasms

Intervention

Radiation:
• capecitabine and concurrent intensity modulated radiotherapy
patients with rectal cancer undergoing capecitabine and concurrent intensity modulated radiotherapy

Locations

Country	Name	City	State
China	General Hospital of Ningxia Medical University	Yinchuan	Ningxia

Sponsors (1)

Lead Sponsor	Collaborator
General Hospital of Ningxia Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	overall survival		5years	Yes
Secondary	grade 3 or higher treatment related small bowel toxicity		5years	Yes