S-1-induced Lacrimal Drainage Obstruction

Study Overview
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Brief Summary
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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.

Official Title
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Lacrimal Drainage Obstruction in Gastric Cancer Patients Receiving Adjuvant S-1 Chemotherapy: A Prospective Study

Conditions
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Gastric Cancer

Intervention / Treatment
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* Drug: S-1


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| GC patients receiving adjuvant S-1 chemotherapy<br> | Drug: S-1<br>* Adjuvant S-1 chemotherapy will be performed to GC patients receiving curative D2 gastric surgery<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The incidence of LDO | The cumulative incidence of LDO during the 1 year after adjuvant S1 chemotherapy will be analyzed | The incidence of LDO (1 year) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Adjuvant chemotherapy