Nursing and Pharmacy Care Between Capecitabine and 5-Fluoruracil Regimens

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Gastric Cancer

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aged 18 or above Diagnosed with AEGC and were prescribed with either XELOX-based or FOLFOX4- based chemotherapy treatment Exclusion Criteria: Persons < 18 years of age; Pregnant or lactating women; Persons related unequally to investigators (e.g. student, employee); Special population (e.g. prisoner, mentally, congnitively disabled); Patients who refused to sign consent or not willing to participate.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| XELOX<br>Capecitabine (Xeloda) 1000mg/m2 po bid x 14 days Oxaliplatin (Eloxatin) 130mg/m2 iv over 2 hrs d1 Q3w x 8 cycles | |
| XP<br>Cisplatin (CDDP) 80 mg/m2 iv over 3 hrs d1 Capecitabine (Xeloda) 1000 mg/m2 po bid d1-14, Q3w | |
| FOLFOX<br>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 | |
| FP<br>Cisplatin (CDDP) 100 mg/m2 iv d1 5-FU 1000 mg/m2/d civi d1-5, Q4w | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |