Nursing and Pharmacy Care Between Capecitabine and 5-Fluoruracil Regimens

Gastric Cancer Clinical Trial

Official title:

The Impact of Nursing and Pharmacy Care Between Capecitabine and 5-Fluoruracil Regimens in the Management of Advanced Esophago-gastric Cancer in Hong Kong

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02063412
• Other study ID #: Roche-TR116583
• Secondary ID: TR116583VLKZ003
• Status: Withdrawn
• Phase: N/A
• First received: February 13, 2014
• Last updated: February 1, 2017
• Start date: August 2013
• Est. completion date: April 2014

Study information

• Verified date: February 2017
• Source: Chinese University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The objective of this study is to compare the possible time savings from reduction of nursing and pharmacy time to manage AEGC patients using capecitabine-based regimens versus traditional intravenous chemotherapy in the Hong Kong public hospital setting.

Description:

Advanced esophageal and gastric cancer (AEGC) have ranked in the top 10 cancer-related cause of death worldwide, with approximately one million new cases each year. Over half of new cases are in East Asia. The traditional chemotherapy for AEGC remains on intravenous (IV) fluorouracil (5-FU), cisplatin, and the anthracyclines. Trials favoured the combined use of 5-FU and cisplatin for superior efficacy and quality of life in AEGC patients. 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 AEGC patients. In addition, 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 However, there is a lack of local data to demonstrate the impact of pharmacy and nursing care utilizing capecitabine-based regimen comparing to traditional IV chemotherapy in MCRC patients of Hong Kong.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: April 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

1. Aged 18 or above

2. Diagnosed with AEGC and were prescribed with either XELOX-based or FOLFOX4- based chemotherapy treatment

Exclusion Criteria:

1. Persons < 18 years of age;

2. Pregnant or lactating women;

3. Persons related unequally to investigators (e.g. student, employee);

4. Special population (e.g. prisoner, mentally, congnitively disabled);

5. Patients who refused to sign consent or not willing to participate.

Related Conditions & MeSH terms

• Gastric Cancer
• Stomach Neoplasms

Locations

Country	Name	City	State
n/a

Sponsors (4)

Lead Sponsor	Collaborator
Vivian Wing Yan Lee	Hoffmann-La Roche, Princess Margaret Hospital, Hong Kong, Queen Elizabeth Hospital, Hong Kong

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Composite preparation, dispensing, and administration time	This is a time-and-motion study conducted in 2 public hospitals of Hong Kong based on the simulation of previously data on both capecitabine-based regimen (XELOX and XP) and IV 5-FU-based regimen (FOLFOX and FP)	Up to 6 months after initiation of chemotherapy