S-1-induced Lacrimal Drainage Obstruction
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01486472|
Recruitment Status : Unknown
Verified December 2011 by Keun-Wook Lee, Seoul National University Bundang Hospital.
Recruitment status was: Recruiting
First Posted : December 6, 2011
Last Update Posted : December 7, 2011
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.
|Condition or disease||Intervention/treatment|
|Gastric Cancer||Drug: S-1|
|Study Type :||Observational|
|Estimated Enrollment :||200 participants|
|Official Title:||Lacrimal Drainage Obstruction in Gastric Cancer Patients Receiving Adjuvant S-1 Chemotherapy: A Prospective Study|
|Study Start Date :||November 2010|
|Estimated Primary Completion Date :||December 2012|
|Estimated Study Completion Date :||December 2013|
|GC patients receiving adjuvant S-1 chemotherapy||
Adjuvant S-1 chemotherapy will be performed to GC patients receiving curative D2 gastric surgery
- The incidence of LDO [ Time Frame: The incidence of LDO (1 year) ]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 LDOCorrelation 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01486472
|Contact: Keun-Wook Lee, M.D. & Ph.D.||firstname.lastname@example.org|
|Contact: Namju Kim, M.D.||email@example.com|
|Korea, Republic of|
|Seoul National University Bundang Hospital||Recruiting|
|Seongnam, Gyeonggi-do, Korea, Republic of, 463-707|
|Contact: Keun-Wook Lee Lee, M.D. & Ph.D. 82-31-787-7009 firstname.lastname@example.org|
|Contact: Namju Kim, M.D. 82-31-787-7376 email@example.com|
|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|