Trial Outcomes & Findings for Cost-minimization Analysis of Gastric Cancer Treatments in Hong Kong (NCT NCT01679054)
NCT ID: NCT01679054
Last Updated: 2024-03-12
Results Overview
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.
Recruitment status
COMPLETED
Target enrollment
58 participants
Primary outcome timeframe
At the completion of respective chemotherapy regimen, up to 6 months
Results posted on
2024-03-12
Participant Flow
Participant milestones
| Measure |
Epirubicin + Oxaliplatin + Capecitabine (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
|
|---|---|---|
|
Overall Study
STARTED
|
45
|
13
|
|
Overall Study
COMPLETED
|
45
|
13
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Cost-minimization Analysis of Gastric Cancer Treatments in Hong Kong
Baseline characteristics by cohort
| Measure |
Epirubicin + Oxaliplatin + Capecitabine (EOX)
n=45 Participants
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
n=13 Participants
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
|
Total
n=58 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
40 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
52 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
5 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Age, Continuous
|
56.6 years
STANDARD_DEVIATION 10 • n=5 Participants
|
56.5 years
STANDARD_DEVIATION 13.3 • n=7 Participants
|
56.5 years
STANDARD_DEVIATION 12.1 • n=5 Participants
|
|
Sex: Female, Male
Female
|
19 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
26 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
45 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
58 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
Hong Kong
|
45 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
58 Participants
n=5 Participants
|
|
ECOG Performance Scores < 2
|
42 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
52 Participants
n=5 Participants
|
|
ECOG Performance Score >= 2
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: At the completion of respective chemotherapy regimen, up to 6 monthsExpected 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.
Outcome measures
| Measure |
EOX (Epirubicin, Oxaliplatin, Xeloda®- Capecitabine)
n=45 Participants
It consists of an intravenous bolus injection of epirubicin 50 mg/m2 and an intravenous infusion of oxaliplatin 130 mg/m2 over 2 hours on day 1 of every 3 week cycles, together with oral capecitabine tablets 625 mg/m2 twice daily for six months.
|
FOLFOX4 (5-fluorouracil (5-FU), Leucovorin, Oxaliplatin)
n=13 Participants
It consists of an intravenous infusion of oxaliplatin 85 mg/m2 over 2 hours on day 1, and an intravenous infusion of folinic acid (leucovorin) 200 mg/m2 over 2 hours on days 1 and 2. This is followed by an intravenous bolus injection of 5-FU 400 mg/m2 and then continuous intravenous infusion of 5-FU 600 mg/m2 over 22 hours every 2 weeks.
|
|---|---|---|
|
Expected and Unexpected Provider Costs
Expected Medication Cost
|
2264.1 HK$
Standard Deviation 354.5
|
522 HK$
Standard Deviation 104.5
|
|
Expected and Unexpected Provider Costs
Expected Laboratory Tests
|
1135.7 HK$
Standard Deviation 294.3
|
846 HK$
Standard Deviation 200.2
|
|
Expected and Unexpected Provider Costs
Expected Day ward/inpatient visits
|
600 HK$
Standard Deviation 0
|
9900 HK$
Standard Deviation 0
|
|
Expected and Unexpected Provider Costs
Expected X rays & Scans
|
760.3 HK$
Standard Deviation 361.2
|
846.9 HK$
Standard Deviation 367.6
|
|
Expected and Unexpected Provider Costs
Expected Outpatient visits
|
1094.3 HK$
Standard Deviation 263
|
864.8 HK$
Standard Deviation 163.2
|
|
Expected and Unexpected Provider Costs
Unexpected Medication Cost
|
116.2 HK$
Standard Deviation 255.4
|
112.3 HK$
Standard Deviation 169.9
|
|
Expected and Unexpected Provider Costs
Unexpected Emergency unit visit
|
39.5 HK$
Standard Deviation 74.3
|
85.8 HK$
Standard Deviation 109.6
|
|
Expected and Unexpected Provider Costs
Unexpected Hosptial Bed-days
|
1531.4 HK$
Standard Deviation 4607.9
|
2830.5 HK$
Standard Deviation 4358.6
|
|
Expected and Unexpected Provider Costs
Unexpected Laboratory Tests
|
297 HK$
Standard Deviation 256.9
|
497.5 HK$
Standard Deviation 470.5
|
|
Expected and Unexpected Provider Costs
Unexpected Outpatient visits
|
344.1 HK$
Standard Deviation 251.3
|
404.7 HK$
Standard Deviation 433.3
|
|
Expected and Unexpected Provider Costs
Total Unexpected Cost/cycle
|
2540.1 HK$
Standard Deviation 5064.4
|
4246.4 HK$
Standard Deviation 4875.1
|
|
Expected and Unexpected Provider Costs
Total Unexpected Cost/patient
|
13434.0 HK$
Standard Deviation 26785.2
|
33546.6 HK$
Standard Deviation 38250.8
|
|
Expected and Unexpected Provider Costs
Total Cost/patient
|
44397.1 HK$
Standard Deviation 27105.7
|
135387.9 HK$
Standard Deviation 39084.0
|
|
Expected and Unexpected Provider Costs
Unexpected X rays & Scans
|
211.8 HK$
Standard Deviation 520.1
|
315.6 HK$
Standard Deviation 785.5
|
SECONDARY outcome
Timeframe: At the completion of respective chemotherapy regimen, up to 6 monthsExpected and unexpected societal costs (patient time, travel)
Outcome measures
| Measure |
EOX (Epirubicin, Oxaliplatin, Xeloda®- Capecitabine)
n=45 Participants
It consists of an intravenous bolus injection of epirubicin 50 mg/m2 and an intravenous infusion of oxaliplatin 130 mg/m2 over 2 hours on day 1 of every 3 week cycles, together with oral capecitabine tablets 625 mg/m2 twice daily for six months.
|
FOLFOX4 (5-fluorouracil (5-FU), Leucovorin, Oxaliplatin)
n=13 Participants
It consists of an intravenous infusion of oxaliplatin 85 mg/m2 over 2 hours on day 1, and an intravenous infusion of folinic acid (leucovorin) 200 mg/m2 over 2 hours on days 1 and 2. This is followed by an intravenous bolus injection of 5-FU 400 mg/m2 and then continuous intravenous infusion of 5-FU 600 mg/m2 over 22 hours every 2 weeks.
|
|---|---|---|
|
Expected and Unexpected Societal Costs
Expected Patient Time Cost
|
544 HK$
Standard Deviation 154.4
|
1013.1 HK$
Standard Deviation 471.4
|
|
Expected and Unexpected Societal Costs
Expected Patient Travel Cost
|
402.7 HK$
Standard Deviation 290.5
|
236.6 HK$
Standard Deviation 118.5
|
|
Expected and Unexpected Societal Costs
Expected Patient Treatment Cost
|
3097.1 HK$
Standard Deviation 468.1
|
2322.5 HK$
Standard Deviation 267.7
|
|
Expected and Unexpected Societal Costs
Total Expected Cost/Cycle
|
4043.7 HK$
Standard Deviation 707.7
|
3572.2 HK$
Standard Deviation 354.9
|
|
Expected and Unexpected Societal Costs
Total Expected Cost/Patient
|
21386.7 HK$
Standard Deviation 3742.7
|
28220.4 HK$
Standard Deviation 2784.8
|
|
Expected and Unexpected Societal Costs
Unexpected Patient Time Cost
|
323.3 HK$
Standard Deviation 489.2
|
306.3 HK$
Standard Deviation 400.3
|
|
Expected and Unexpected Societal Costs
Unexpected Patient Travel Cost
|
106.2 HK$
Standard Deviation 110.7
|
69.5 HK$
Standard Deviation 63.5
|
|
Expected and Unexpected Societal Costs
Unexpected Patient Treatment Cost
|
84.6 HK$
Standard Deviation 141.1
|
134.7 HK$
Standard Deviation 137.6
|
|
Expected and Unexpected Societal Costs
Total Unexpected Cost/Cycle
|
514.1 HK$
Standard Deviation 645
|
510.5 HK$
Standard Deviation 538.1
|
|
Expected and Unexpected Societal Costs
Total Cost/Patient
|
2719.3 HK$
Standard Deviation 3517
|
4033 HK$
Standard Deviation 4221.7
|
Adverse Events
EOX (Epirubicin, Oxaliplatin, Xeloda®- Capecitabine)
Serious events: 0 serious events
Other events: 22 other events
Deaths: 0 deaths
FOLFOX4 (5-fluorouracil (5-FU), Leucovorin, Oxaliplatin)
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
EOX (Epirubicin, Oxaliplatin, Xeloda®- Capecitabine)
n=45 participants at risk
It consists of an intravenous bolus injection of epirubicin 50 mg/m2 and an intravenous infusion of oxaliplatin 130 mg/m2 over 2 hours on day 1 of every 3 week cycles, together with oral capecitabine tablets 625 mg/m2 twice daily for six months.
|
FOLFOX4 (5-fluorouracil (5-FU), Leucovorin, Oxaliplatin)
n=13 participants at risk
It consists of an intravenous infusion of oxaliplatin 85 mg/m2 over 2 hours on day 1, and an intravenous infusion of folinic acid (leucovorin) 200 mg/m2 over 2 hours on days 1 and 2. This is followed by an intravenous bolus injection of 5-FU 400 mg/m2 and then continuous intravenous infusion of 5-FU 600 mg/m2 over 22 hours every 2 weeks.
|
|---|---|---|
|
Gastrointestinal disorders
Nausea and Vomiting
|
48.9%
22/45 • Number of events 30
|
53.8%
7/13 • Number of events 14
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place