Gastric CancerNCT01679054
Cost-minimization Analysis of Gastric Cancer Treatments in Hong Kong
An observational study of Gastric Cancer, run by Vivian Wing Yan Lee at 1 site in Hong Kong.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastric Cancer
- Type of treatment
- Injection or infusion
- How many people
- 58 participants
- Where
- 1 siteHong Kong
- Study dates
- Oct 2011to Jul 2012
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: CDARS data will be accessed at respective sites to identify patients with aGC who have completed either EOX or EOF regimens.
Who may be able to join
- Patients who were diagnosed with gastric cancer and completed either EOX or EOF chemotherapy treatment
Who cannot join
- Patients less than 18 years of age
- Patient who did not meet inclusion criteria
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cost-minimization Analysis of Xeloda® vs 5-fluorouracil-based Treatment for Gastric Cancer Patients in Hong Kong
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.
Read the 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 treatment2,3. 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, respectively5,6. 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 advanced/metastatic 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, liver/renal 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.
- Conditions
- Gastric Cancer
- Keywords
- Neoplasm, Gastric Cancer, Cost
- Medical subject headings
- Stomach Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| EOX | Epirubicin + Oxaliplatin + Capecitabine (EOX) Epirubicin 50 mg/m2 iv bolus d1 q3w x 8 cycles Oxaliplatin (Eloxatin) 130 mg/m2 iv over 2 hours d1 q3w x 8 cycles Capecitabine (Xeloda) 625 mg/m2 po bid x 6 months | |
| FOLFOX4 | 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Expected and Unexpected Provider Costs
Expected and unexpected provider costs (chemotherapy, hospital stay, lab tests, clinic visits, AE management, other drug costs). The costs for healthcare resources usage, including hospital visits and laboratory investigations, were valued according to the Hong Kong Government Gazette 2003, which is the most updated version of official source for costs of public hospital services.
Measured: At the completion of respective chemotherapy regimen, up to 6 months
Secondary outcomes (1)
Expected and Unexpected Societal Costs
Expected and unexpected societal costs (patient time, travel)
Measured: At the completion of respective chemotherapy regimen, up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2012 (estimated)
- Study startOct 2011
- Primary completionJul 2012
- Study completionJul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Gastric CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vivian Wing Yan Lee
- Sponsor type
- University, hospital or other
- Collaborators
- Hoffmann-La Roche, Princess Margaret Hospital, Hong Kong, Pamela Youde Nethersole Eastern Hospital
- Responsible party
- Sponsor-investigator, Vivian Wing Yan Lee, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01679054
- Sponsor's protocol ID
- Roche-TR116582
- Other IDs
- TR116582VLKZ001
- Status last verified
- Aug 2023
- First submitted
- 31 Aug 2012
- Last updated
- 12 Mar 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cost-minimization Analysis of Xeloda® vs 5-fluorouracil-based Treatment for Gastric Cancer Patients in Hong Kong
- ClinicalTrials.gov ID
- NCT01679054
- Acronym / sponsor ID
- Roche-TR116582
- Conditions
- Gastric Cancer
- Keywords
- Neoplasm, Gastric Cancer, Cost
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Vivian Wing Yan LeeUniversity, hospital or other
- Collaborators
- Hoffmann-La Roche, Princess Margaret Hospital, Hong Kong, Pamela Youde Nethersole Eastern Hospital
- Study start
- Oct 2011
- Primary completion
- Jul 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 5 Sep 2012 (estimated)
- Results
- Posted 12 Mar 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 treatment2,3. 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, respectively5,6. 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 advanced/metastatic 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, liver/renal 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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EOX | – | –Epirubicin + Oxaliplatin + Capecitabine (EOX) Epirubicin 50 mg/m2 iv bolus d1 q3w x 8 cycles Oxaliplatin (Eloxatin) 130 mg/m2 iv over 2 hours d1 q3w x 8 cycles Capecitabine (Xeloda) 625 mg/m2 po bid x 6 months |
| FOLFOX4 | – | –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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- CDARS data will be accessed at respective sites to identify patients with aGC who have completed either EOX or EOF regimens.
Key inclusion criteria (1 listed)
- Patients who were diagnosed with gastric cancer and completed either EOX or EOF chemotherapy treatment
Key exclusion criteria (2 listed)
- Patients less than 18 years of age
- Patient who did not meet inclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Expected and Unexpected Provider Costs
Time frame: At the completion of respective chemotherapy regimen, up to 6 months
Expected and unexpected provider costs (chemotherapy, hospital stay, lab tests, clinic visits, AE management, other drug costs). The costs for healthcare resources usage, including hospital visits and laboratory investigations, were valued according to the Hong Kong Government Gazette 2003, which is the most updated version of official source for costs of public hospital services.
1 secondary outcome
Expected and Unexpected Societal Costs
Time frame: At the completion of respective chemotherapy regimen, up to 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gastric Cancer, run by Vivian Wing Yan Lee at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Mar 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Expected and Unexpected Provider Costs (time frame: At the completion of respective chemotherapy regimen, up to 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2024.