Rectal CancerNCT03015168
Prognostic Value of Neutrophil-to-lymphocyte Ratio (NLR) on Rectal Cancer Patients
An observational study of Rectal Cancer and Prognosis, run by General Hospital of Ningxia Medical University at 1 site in China.
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). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Rectal Cancer, Prognosis
- What is being tested?
- capecitabine and concurrent intensity modulated radiotherapy
- Type of treatment
- Surgery or procedure
- How many people
- 117 participants
- Where
- 1 siteChina
- Study dates
- Jan 2012to Jan 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients with rectal cancer undergoing capecitabine and concurrent intensity modulated radiotherapy
Who may be able to join
- Patients with locally advanced rectal cancer who received neoadjuvant or adjuvant chemoradiotherapy at our hospital were enrolled in this study.
Who cannot join
- Patients with coexistent autoimmune diseases, infectious diseases, and lacking baseline blood test records were excluded from this study
Trial locations and contacts
1 site in 1 country.
China1 site
General Hospital of Ningxia Medical University
Yinchuan, Ningxia, 750004
About this study
Official title: Prognostic Value of Neutrophil-to-lymphocyte Ratio (NLR) on Rectal Cancer Patients Who Received Capecitabine and Concurrent Intensity Modulated Radiotherapy (IMRT)
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).
Read the 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.
- Conditions
- Rectal Cancer, Prognosis
- Being tested
- capecitabine and concurrent intensity modulated radiotherapy
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
capecitabine and concurrent intensity modulated radiotherapyRadiation
patients with rectal cancer undergoing capecitabine and concurrent intensity modulated radiotherapy
| Study group | Role | What they receive |
|---|---|---|
| Observational Group | Patients with rectal cancer undergoing capecitabine and concurrent intensity modulated radiotherapy Receives: Radiation: capecitabine and concurrent intensity modulated radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
overall survival
Measured: 5years
Secondary outcomes (1)
grade 3 or higher treatment related small bowel toxicity
Measured: 5years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2017 (estimated)
- Study startJan 2012
- Primary completionJan 2017
- Study completionJan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 117 participants (actual)
Sponsor and investigators
- Lead sponsor
- General Hospital of Ningxia Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yan-Yang Wang, M.D., Principal investigator, General Hospital of Ningxia Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03015168
- Sponsor's protocol ID
- Radiation Oncology 201602
- Status last verified
- Jan 2017
- First submitted
- 6 Jan 2017
- Last updated
- 9 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prognostic Value of Neutrophil-to-lymphocyte Ratio (NLR) on Rectal Cancer Patients Who Received Capecitabine and Concurrent Intensity Modulated Radiotherapy (IMRT)
- ClinicalTrials.gov ID
- NCT03015168
- Acronym / sponsor ID
- Radiation Oncology 201602
- Conditions
- Rectal Cancer, Prognosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 117 participants (actual)
- Lead sponsor
- General Hospital of Ningxia Medical UniversityUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Jan 2017 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 9 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observational Group | – | Radiation: capecitabine and concurrent intensity modulated radiotherapyPatients with rectal cancer undergoing capecitabine and concurrent intensity modulated radiotherapy |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with rectal cancer undergoing capecitabine and concurrent intensity modulated radiotherapy
Key inclusion criteria (1 listed)
- Patients with locally advanced rectal cancer who received neoadjuvant or adjuvant chemoradiotherapy at our hospital were enrolled in this study.
Key exclusion criteria (1 listed)
- Patients with coexistent autoimmune diseases, infectious diseases, and lacking baseline blood test records were excluded from this study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| capecitabine and concurrent intensity modulated radiotherapypatients with rectal cancer undergoing capecitabine and concurrent intensity modulated radiotherapy | Radiation | Observational Group |
Primary outcome
overall survival
Time frame: 5years
1 secondary outcome
grade 3 or higher treatment related small bowel toxicity
Time frame: 5years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yan-Yang Wang, M.D. principal investigator
General Hospital of Ningxia Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rectal Cancer and Prognosis, run by General Hospital of Ningxia Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
overall survival (time frame: 5years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2017.