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Spots Global Cancer Trial Database for S-1-induced Lacrimal Drainage Obstruction

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Trial Identification

Brief Title: S-1-induced Lacrimal Drainage Obstruction

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

Study ID: NCT01486472

Conditions

Gastric Cancer

Interventions

S-1

Study Description

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:

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

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

Contact Details

Name: Keun-Wook Lee, M.D. & Ph.D.

Affiliation: Department of Internal Medicine, Seoul National University Bundang Hospital

Role: PRINCIPAL_INVESTIGATOR

Name: Namju Kim, M.D.

Affiliation: Department of Opthalmology, Seoul National University Bundang Hospital

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

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