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| ID | Type | Description | Link |
|---|---|---|---|
| TR116581VLKZ002 | Other Identifier | CUHK |
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Slow recruitment pace
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| Name | Class |
|---|---|
| Hoffmann-La Roche | INDUSTRY |
| Queen Elizabeth Hospital, Hong Kong | OTHER |
| Princess Margaret Hospital, Hong Kong | OTHER_GOV |
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Capital item utilization (hospital bed and infusion pump) | Capital item utilization is measured as the amount of time each healthcare resource is used and the associated cost for usage. | Up to 6 months after the initiation of chemotherapy |
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Inclusion Criteria:
Exclusion Criteria:
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Colorectal patients who were newly prescribed to receive either the XELOX or the FOLOFX4 chemotherapy regimen will be identified from the colorectal clinic.
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| Name | Affiliation | Role |
|---|---|---|
| Vivian WY Lee, PharmD | CUHK | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Princess Margaret Hospital | Kowloon | Hong Kong | ||||
| Queen Elizabeth Hospital |
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| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
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| Kowloon |
| Hong Kong |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |