S-1-induced Lacrimal Drainage Obstruction
Recruitment status was: Recruiting
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.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Lacrimal Drainage Obstruction in Gastric Cancer Patients Receiving Adjuvant S-1 Chemotherapy: A Prospective Study|
- The incidence of LDO [ Time Frame: The incidence of LDO (1 year) ] [ Designated as safety issue: No ]The cumulative incidence of LDO during the 1 year after adjuvant S1 chemotherapy will be analyzed
- Correlation between the concentration of S-1-related chemical compounds and the developement of LDO [ Designated as safety issue: No ]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
Biospecimen Retention: Samples Without DNA
|Study Start Date:||November 2010|
|Estimated Study Completion Date:||December 2013|
|Estimated Primary Completion Date:||December 2012 (Final data collection date for primary outcome measure)|
|GC patients receiving adjuvant S-1 chemotherapy||
Adjuvant S-1 chemotherapy will be performed to GC patients receiving curative D2 gastric surgery
Please refer to this study by its ClinicalTrials.gov identifier: NCT01486472
|Korea, Republic of|
|Seoul National University Bundang Hospital|
|Seongnam, Gyeonggi-do, Korea, Republic of, 463-707|
|Principal Investigator:||Keun-Wook Lee, M.D. & Ph.D.||Department of Internal Medicine, Seoul National University Bundang Hospital|
|Principal Investigator:||Namju Kim, M.D.||Department of Opthalmology, Seoul National University Bundang Hospital|