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Trial record 63 of 159 for:    colon cancer AND Capecitabine AND Fluorouracil

Nursing and Pharmacy Time for Delivering Xeloda® Versus 5-Fluoruracil Regimens

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ClinicalTrials.gov Identifier: NCT01801085
Recruitment Status : Terminated (Slow recruitment pace)
First Posted : February 28, 2013
Last Update Posted : February 2, 2017
Sponsor:
Collaborators:
Hoffmann-La Roche
Queen Elizabeth Hospital, Hong Kong
Princess Margaret Hospital, Hong Kong
Information provided by (Responsible Party):
Vivian Wing Yan Lee, Chinese University of Hong Kong

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.

Condition or disease
Colorectal Cancer

Detailed Description:
Colorectal cancer (CRC) is the second most common cause of cancer-related death in Hong Kong. The traditional chemotherapy for CRC remains on intravenous (IV) fluorouracil (5-FU) based regimens with the response rates of 10-20% and a median survival of approximately one year. Recent years, oral chemotherapy has a more practical and economic advantages over IV regimen. It is understandable that patients prefer oral regimens as long as the clinical efficacy is maintained. Oral treatment strategy preserves quality of life for CRC patients. In a previous cost-minimization study conducted in Hong Kong, it was demonstrated that capecitabine was more cost-effective than 5-FU plus oxaliplatin assuming they had equal clinical efficacy. Not only is capecitabine more cost-effective, it may also have additional cost saving in the nursing and pharmacy time . It is because a significant amount of time can be saved in both nursing and pharmacy for the preparation and administration of IV chemotherapy. In the UK, it was demonstrated that capecitabine required less pharmacy and administration time per cycle than 5-FU based IV chemotherapy. However, there is a lack of local data to demonstrate the impact of pharmacy and nursing care utilizing capecitabine comparing to traditional IV chemotherapy in CRC patients of Hong Kong.

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Study Type : Observational
Actual Enrollment : 21 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Impact of Nursing and Pharmacy Care Between Xeloda® and 5-Fluoruracil Regimens in the Management of Colorectal Cancer (CRC) in Hong Kong
Study Start Date : October 2011
Actual Primary Completion Date : December 2014
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine


Group/Cohort
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



Primary Outcome Measures :
  1. Composite preparation, dispensing and administration time [ Time Frame: Up to 6 months after the initiation of chemotherapy ]
    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.


Secondary Outcome Measures :
  1. Capital item utilization (hospital bed and infusion pump) [ Time Frame: Up to 6 months after the initiation of chemotherapy ]
    Capital item utilization is measured as the amount of time each healthcare resource is used and the associated cost for usage.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Colorectal patients who were newly prescribed to receive either the XELOX or the FOLOFX4 chemotherapy regimen will be identified from the colorectal clinic.
Criteria

Inclusion Criteria:

  • Age 18 or above
  • Diagnosed with CRC and prescribed with either XELOX for FOLFOX4 chemotherapy treatment

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

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): NCT01801085


Locations
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Hong Kong
Princess Margaret Hospital
Kowloon, Hong Kong
Queen Elizabeth Hospital
Kowloon, Hong Kong
Sponsors and Collaborators
Vivian Wing Yan Lee
Hoffmann-La Roche
Queen Elizabeth Hospital, Hong Kong
Princess Margaret Hospital, Hong Kong
Investigators
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Principal Investigator: Vivian WY Lee, PharmD CUHK

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Responsible Party: Vivian Wing Yan Lee, Associate Professor, Chinese University of Hong Kong
ClinicalTrials.gov Identifier: NCT01801085     History of Changes
Other Study ID Numbers: Roche-TR116581
TR116581VLKZ002 ( Other Identifier: CUHK )
First Posted: February 28, 2013    Key Record Dates
Last Update Posted: February 2, 2017
Last Verified: February 2017
Keywords provided by Vivian Wing Yan Lee, Chinese University of Hong Kong:
Time-and-Motion
Neoplasm
Colorectal Cancer
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Colonic Diseases
Capecitabine
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents