Cost-minimization Analysis of Gastric Cancer Treatments in Hong Kong

NCT01679054 | Completed Results

• 2 other identifiers: Roche-TR116582TR116582VLKZ001
• Study Type: observational
• Target: 58
• Locations: 1 country
• Sites: 1

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.

Conditions

Gastric Cancer

Keywords

Neoplasm; Gastric Cancer; Cost

Outcome Measures

Primary Outcomes (1)

• 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.

  At the completion of respective chemotherapy regimen, up to 6 months

Secondary Outcomes (1)

• Expected and Unexpected Societal Costs

  At the completion of respective chemotherapy regimen, up to 6 months

Study Arms (2)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

CDARS data will be accessed at respective sites to identify patients with aGC who have completed either EOX or EOF regimens.

You may qualify if:

• Patients who were diagnosed with gastric cancer and completed either EOX or EOF chemotherapy treatment

You may not qualify if:

• Patients less than 18 years of age

Sponsors & Collaborators

• Vivian Wing Yan Lee: lead
• Hoffmann-La Roche: collaborator
• Princess Margaret Hospital, Hong Kong: collaborator
• Pamela Youde Nethersole Eastern Hospital: collaborator

Study Sites (1)

Princess Margaret Hospital

Kowloon, Hong Kong

Location

MeSH Terms

Conditions

Stomach Neoplasms; Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Limitations and Caveats

1\. A total of 58 subjects were identified with only thirteen in the FOLFOX4 arm. The two groups were then arranged for comparison in an approximate 3:1 ratio (45 EOX and 13 FOLFOX4). More patients seem to have chosen EOX over FOLFOX4 to avoid the inpatient stay for the prolonged administration of FOLFOX4

Results Point of Contact

• Title: Vivian Lee
• Organization: The Chinese University of Hong Kong

vivianlee@cuhk.edu.hk

+85239438012

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: August 31, 2012
• First Posted: September 5, 2012
• Study Start: October 1, 2011
• Primary Completion: July 1, 2012
• Study Completion: July 1, 2012
• Last Updated: March 12, 2024
• Results First Posted: March 12, 2024

Record last verified: 2023-08

Locations

HK (1)