Concentration of S-1 Metabolites in Tear and Plasma of Patients Receiving TS-1

Gastric Cancer Clinical Trial

Official title:

Concentration of S-1 Metabolites in Tear and Plasma and Correlation With Its Side Effects in Patients Receiving S-1 Adjuvant Chemotherapy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01621919
• Other study ID #: TITAP
• Status: Recruiting
• Phase: N/A
• First received: June 14, 2012
• Last updated: June 14, 2012
• Start date: December 2010
• Est. completion date: May 2013

Study information

• Verified date: June 2012
• Source: Seoul National University Bundang Hospital
• Contact: Keon-Wook Lee, MD
• Phone: 82-31-787-7073
• Email: hmodocto[@]hanmail.net
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

S-1 has been also shown to be an effective drug for palliative chemotherapy in Eastern and Western GC patients. Recently, some case and small-sized studies have been reported on lacrimal drainage obstruction(LDO)caused by S-1.Suggested mechanism of LDO involves direct secretion of S-1 into the tear; thus the concentration of S-1 metabolite in tear is expected to be high in patients who developed LDO than in patients without LDO. We investigate the concentration of S-1 and its metabolites in tear and plasma and find out its correlation with side effects such as LDO. These results will also help us identify patients who are at high risk of developing S-1-associated side effects.

Description:

1. S-1 metabolites concentration in plasma

1. factors affecting plasma concentration

• surgery subtype

• serum creatinine

2. systemic adverse effects of S-1 and its correlation with plasma S-1 metabolites concentration

• enteritis

• fatigue

2. S-1 metabolites concentration in tears

1. correlation of tear concentration with plasma concentration

2. lacrimal drainage obstruction caused by S-1 administration, and its correlation with tear S-1 metabolites concentration

3. lacrimal drainage obstruction caused by S-1 administration, and its correlation with plasma S-1 metabolites concentration

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: May 2013
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Patients who received radical surgery for gastric cancer

• Patients who receiving S-1 adjuvant chemotherapy

• Patients who administrated S-1 for more than 7 days

Exclusion Criteria:

• who using eyedrop medication

• who has dry eye that tear cannot be sampled

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Gastric Cancer

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam	GYeonggi-do

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Bundang Hospital

Country where clinical trial is conducted

Korea, Republic of,