Study Stopped
Slow recruitment pace
Nursing and Pharmacy Time for Delivering Xeloda® Versus 5-Fluoruracil Regimens
The Impact of Nursing and Pharmacy Care Between Xeloda® and 5-Fluoruracil Regimens in the Management of Colorectal Cancer (CRC) in Hong Kong
2 other identifiers
observational
21
1 country
2
Brief Summary
This is a prospective time-and-motion study to document and compare the time used in preparation, dispensing and administration for capecitabine/oxaliplatin (XELOX) versus IV 5-FU/leucovorin/oxaliplatin (FOLFOX4) regimens in colorectal cancer (CRC) patients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Oct 2011
Typical duration for all trials
2 active sites
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
October 1, 2011
CompletedFirst Submitted
Initial submission to the registry
September 5, 2012
CompletedFirst Posted
Study publicly available on registry
February 28, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2014
CompletedFebruary 2, 2017
February 1, 2017
3.2 years
September 5, 2012
February 1, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Composite preparation, dispensing and administration time
Composite time is measured via real-time recording. Total length of the said time points are to be recorded using a stop-watch and the sum is tabulated in the end.
Up to 6 months after the initiation of chemotherapy
Secondary Outcomes (1)
Capital item utilization (hospital bed and infusion pump)
Up to 6 months after the initiation of chemotherapy
Study Arms (2)
FOLFOX4
Leucovorin 200 mg/m2 iv over 2 hrs before 5-FU, d1 and 2 5-FU 400 mg/m2 iv bolus and then 600 mg/m2 iv over 22 hrs, d 1 and d2 Oxaliplatin (Eloxatin) 85 mg/m2 iv d1 Q2w x 12 cycles
XELOX
Capecitabine (Xeloda) 1000 mg/m2 po bid x 14 days Oxaliplatin (Eloxatin) 130 mg/m2 iv over 2 hrs d1 Q3w x 8 cycles
Eligibility Criteria
Colorectal patients who were newly prescribed to receive either the XELOX or the FOLOFX4 chemotherapy regimen will be identified from the colorectal clinic.
You may qualify if:
- Age 18 or above
- Diagnosed with CRC and prescribed with either XELOX for FOLFOX4 chemotherapy treatment
You may not qualify if:
- Patients less than 18 years of age
- Persons related unequally to investigators
- Patients who are mentally/cognitively disabled
- Patients who refuse to give consent to participate
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Vivian Wing Yan Leelead
- Hoffmann-La Rochecollaborator
- Queen Elizabeth Hospital, Hong Kongcollaborator
- Princess Margaret Hospital, Hong Kongcollaborator
Study Sites (2)
Princess Margaret Hospital
Kowloon, Hong Kong
Queen Elizabeth Hospital
Kowloon, Hong Kong
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Vivian WY Lee, PharmD
CUHK
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
September 5, 2012
First Posted
February 28, 2013
Study Start
October 1, 2011
Primary Completion
December 1, 2014
Study Completion
December 1, 2014
Last Updated
February 2, 2017
Record last verified: 2017-02