Overview

This trial is active, not recruiting.

Condition gastric cancer
Sponsor Vivian Wing Yan Lee
Collaborator Hoffmann-La Roche
Start date August 2013
End date April 2014
Trial size 60 participants
Trial identifier NCT02063412, Roche-TR116583, TR116583VLKZ003

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Time perspective cross-sectional
Arm
Capecitabine (Xeloda) 1000mg/m2 po bid x 14 days Oxaliplatin (Eloxatin) 130mg/m2 iv over 2 hrs d1 Q3w x 8 cycles
Cisplatin (CDDP) 80 mg/m2 iv over 3 hrs d1 Capecitabine (Xeloda) 1000 mg/m2 po bid d1-14, Q3w
Leucovorin 200 mg/m2 iv over 2 hrs before 5-FU, d1 and d2 5-FU 400mg/m2 iv bolus and then 600 mg/m2 iv over 22 hrs, d1 and d2 Q2w
Cisplatin (CDDP) 100 mg/m2 iv d1 5-FU 1000 mg/m2/d civi d1-5, Q4w

Primary Outcomes

Measure
Composite preparation, dispensing, and administration time
time frame: Up to 6 months after initiation of chemotherapy

Eligibility Criteria

Male or female participants from 18 years up to 85 years old.

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.

Additional Information

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
Principal investigator Vivian WY Lee, PharmD
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.
Trial information was received from ClinicalTrials.gov and was last updated in February 2014.
Information provided to ClinicalTrials.gov by Chinese University of Hong Kong.