NCT03015168

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
117

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2012

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2017

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

January 6, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 9, 2017

Completed
Last Updated

January 9, 2017

Status Verified

January 1, 2017

Enrollment Period

5 years

First QC Date

January 6, 2017

Last Update Submit

January 6, 2017

Conditions

Rectal CancerPrognosis

Outcome Measures

Primary Outcomes (1)

  • overall survival

    5years

Secondary Outcomes (1)

  • grade 3 or higher treatment related small bowel toxicity

    5years

Study Arms (1)

Observational Group

Patients with rectal cancer undergoing capecitabine and concurrent intensity modulated radiotherapy

Radiation: capecitabine and concurrent intensity modulated radiotherapy

Interventions

capecitabine and concurrent intensity modulated radiotherapyRADIATION

patients with rectal cancer undergoing capecitabine and concurrent intensity modulated radiotherapy

Observational Group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

patients with rectal cancer undergoing capecitabine and concurrent intensity modulated radiotherapy

You may qualify if:

  • Patients with locally advanced rectal cancer who received neoadjuvant or adjuvant chemoradiotherapy at our hospital were enrolled in this study.

You may not qualify if:

  • Patients with coexistent autoimmune diseases, infectious diseases, and lacking baseline blood test records were excluded from this study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

General Hospital of Ningxia Medical University

Yinchuan, Ningxia, 750004, China

Location

MeSH Terms

Conditions

Rectal Neoplasms

Interventions

Capecitabine

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesIntestinal DiseasesRectal Diseases

Intervention Hierarchy (Ancestors)

DeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsFluorouracilUracilPyrimidinonesDeoxyribonucleosidesNucleosidesNucleic Acids, Nucleotides, and Nucleosides

Study Officials

  • Yan-Yang Wang, M.D.

    General Hospital of Ningxia Medical University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 6, 2017

First Posted

January 9, 2017

Study Start

January 1, 2012

Primary Completion

January 1, 2017

Study Completion

January 1, 2017

Last Updated

January 9, 2017

Record last verified: 2017-01

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)