S-1-induced Lacrimal Drainage Obstruction

• Conditions: Gastric Cancer
• Interventions: Drug: S-1

• Registration Number: NCT01486472
• Lead Sponsor: Seoul National University Bundang Hospital

Brief Summary

S-1 is an effective drug in gastric cancer (GC) for palliative chemotherapy in Eastern and Western patients. Recently, S-1 has been also reported to be an effective adjuvant therapy for GC patients who received D2 surgery in Eastern Asian patients.

Recently, the development of lacrimal drainage obstruction (LDO) caused by S-1 has been reported from some case and small-sized studies. The incidence of developing LDO has been estimated to about 15\~20% of patients receiving S-1 therapy in some retrospective studies. However, there is no prospective report on the incidence of LDO in patients receiving S-1 chemotherapy. Moreover, the mechanism of developing S-1-induced LDO has not been systemically studied until now. Suggested mechanism of LDO involves direct secretion of S-1 into the tear.

Therefore, this study was initiated to prospectively investigate the incidence of LDO in GC patients receiving adjuvant S-1 chemotherapy. In addition, the correlation between the development of LDO and the concentration of S-1 (or its metabolites) in tear and plasma will be explored. These results will help clinicians identify patients who are at high risk of developing S-1-associated LDO.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-11
• Status Verified: 2011-12
• Study First Submitted: 2011-12-02
• Study First Submitted QC: 2011-12-05
• Study First Posted: 2011-12-06
• Last Update Submitted: 2011-12-06
• Last Update Posted: 2011-12-07
• Primary Completion: 2012-12
• Study Completion: 2013-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• Patients who received curative (R0) surgery for GC
• Patients receiving adjuvant S-1 chemotherapy
• Patients with adequate major organ functions for chemotherapy
• Patient who have taken S-1 at least 7 days (for blood and tear sampling)

Exclusion Criteria

• Patients who are not candidate for adjuvant S-1 chemotherapy
• Patients with previous history of LDO
• Patients with other opthalmologic disease who are not appropriate to be included in this study (i.e., patients using eyedrop medication; patients with dry eye whose tears cannot be sampled)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
GC patients receiving adjuvant S-1 chemotherapy	S-1	-

Primary Outcome Measures

Name	Time	Method
The incidence of LDO	The incidence of LDO (1 year)	The cumulative incidence of LDO during the 1 year after adjuvant S1 chemotherapy will be analyzed

Secondary Outcome Measures

Name	Time	Method
Correlation between the concentration of S-1-related chemical compounds and the developement of LDO		Correlation between the concentration of S-1-related chemical compounds (5-FU or other components) and the risk of developing LDO will be investigated. Plasma and tear samples will be aquired during the chemotherapy

Trial Locations

Locations (1)

Seoul National University Bundang Hospital; 🇰🇷 Seongnam, Gyeonggi-do, Korea, Republic of