Ignite Creation Date:
2024-05-06 @ 12:51 AM
Last Modification Date:
2024-10-26 @ 10:56 AM
Study NCT ID:
NCT01679054
Status:
COMPLETED
Last Update Posted:
2024-03-12
First Post:
2012-08-31
Brief Title:
Cost-minimization Analysis of Gastric Cancer Treatments in Hong Kong
Sponsor:
Vivian Wing Yan Lee
Organization:
Chinese University of Hong Kong
Study Overview
Official Title:
Cost-minimization Analysis of Xeloda vs 5-fluorouracil-based Treatment for Gastric Cancer Patients in Hong Kong
Status:
COMPLETED
Status Verified Date:
2023-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a retrospective cost-minimization analysis study to compare the costs of treatment with EOF vs EOX regimens in patients with gastric cancer GC in Hong Kong Patient baseline characteristics and cost data will be extracted from records and compared
Detailed Description:
Background
The oral chemotherapy agent Xeloda was recently extended by the Hong Kong Hospital Authority as subsidized therapy for the treatment of colorectal cancer1 Xeloda-based chemotherapy regimen has shown to be more cost-effective than 5-fluorouracil 5-FU considering they had equivalent clinical efficacy in colorectal cancer treatment23 The total cost for 5-FU-based regimen was higher for the healthcare provider and society as a whole Gastric cancer ranks fourth in cancer-related cause of death in the Hong Kong population4 5-FU has known antitumor activity and has been used successfully in advanced gastric cancer aGC with cisplatin FP as well as with oxaliplatin epirubicin FOLFOX4 EOF When substituted with Xeloda the XP and EOX regimens have demonstrated to be noninferior in terms of progression-free survival when compared with FP and EOF respectively56 In an economics evaluation done by the manufacturer for NICE submission on the use of Xeloda for treatment of aGC the use of XP regimen allowed a cost reduction while eliminating possible complication related to intravenous therapy7 Moreover FOLFOX4 one of the common 5-FU-based regimens used locally has demonstrated to produce a median overall survival of 10 months in advancedmetastatic gastric cancer patients8 An effect similar to that of EOX Currently there is no local data suggesting similar economic impact with Xeloda-based regimen for gastric cancer when compared with 5-FU-based regimens It is worthwhile to see if Xeloda-based therapy for gastric cancer is a cost-effective alternative
Study Objective
To compare retrospective costs of treatment with Xeloda-based and 5-FU-based regiments in patients with advanced gastric cancer in Hong Kong
Methods
This is a retrospective cost-minimization study to be conducted in a public hospital in Hong Kong Sixty 60 gastric cancer patients will be identified from existing case records 30 who completed a Xeloda-based regimen and 30 who completed a 5-FU-based regimen in the study sites Baseline characteristics from both groups prior to chemotherapy including demographics ECOG performance score liverrenal function metastases and survival will be obtained Cost data will also be extracted from patient records
Information to be collected include cost of hospital admission and length of stay outpatient visits diagnostic tests and treatments chemotherapy regimens all other drug therapy adverse side effect management travel and patient time Baseline characteristics and costs will be compared Descriptive statistics will be utilized and sensitivity analysis will be performed to investigate the robustness of the cost model
The oral chemotherapy agent Xeloda was recently extended by the Hong Kong Hospital Authority as subsidized therapy for the treatment of colorectal cancer1 Xeloda-based chemotherapy regimen has shown to be more cost-effective than 5-fluorouracil 5-FU considering they had equivalent clinical efficacy in colorectal cancer treatment23 The total cost for 5-FU-based regimen was higher for the healthcare provider and society as a whole Gastric cancer ranks fourth in cancer-related cause of death in the Hong Kong population4 5-FU has known antitumor activity and has been used successfully in advanced gastric cancer aGC with cisplatin FP as well as with oxaliplatin epirubicin FOLFOX4 EOF When substituted with Xeloda the XP and EOX regimens have demonstrated to be noninferior in terms of progression-free survival when compared with FP and EOF respectively56 In an economics evaluation done by the manufacturer for NICE submission on the use of Xeloda for treatment of aGC the use of XP regimen allowed a cost reduction while eliminating possible complication related to intravenous therapy7 Moreover FOLFOX4 one of the common 5-FU-based regimens used locally has demonstrated to produce a median overall survival of 10 months in advancedmetastatic gastric cancer patients8 An effect similar to that of EOX Currently there is no local data suggesting similar economic impact with Xeloda-based regimen for gastric cancer when compared with 5-FU-based regimens It is worthwhile to see if Xeloda-based therapy for gastric cancer is a cost-effective alternative
Study Objective
To compare retrospective costs of treatment with Xeloda-based and 5-FU-based regiments in patients with advanced gastric cancer in Hong Kong
Methods
This is a retrospective cost-minimization study to be conducted in a public hospital in Hong Kong Sixty 60 gastric cancer patients will be identified from existing case records 30 who completed a Xeloda-based regimen and 30 who completed a 5-FU-based regimen in the study sites Baseline characteristics from both groups prior to chemotherapy including demographics ECOG performance score liverrenal function metastases and survival will be obtained Cost data will also be extracted from patient records
Information to be collected include cost of hospital admission and length of stay outpatient visits diagnostic tests and treatments chemotherapy regimens all other drug therapy adverse side effect management travel and patient time Baseline characteristics and costs will be compared Descriptive statistics will be utilized and sensitivity analysis will be performed to investigate the robustness of the cost model
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| TR116582VLKZ001 | OTHER | CUHK | None |