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S-1-induced Lacrimal Drainage Obstruction

NCT01486472 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 200

Last updated 2011-12-07

No results posted yet for this study

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.

Conditions

Interventions

DRUG

S-1

Adjuvant S-1 chemotherapy will be performed to GC patients receiving curative D2 gastric surgery

Sponsors & Collaborators

  • Seoul National University Bundang Hospital

    lead OTHER

Principal Investigators

  • Keun-Wook Lee, M.D. & Ph.D. · Department of Internal Medicine, Seoul National University Bundang Hospital

  • Namju Kim, M.D. · Department of Opthalmology, Seoul National University Bundang Hospital

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-11-30
Primary Completion
2012-12-31
Completion
2013-12-31

Countries

  • South Korea

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01486472 on ClinicalTrials.gov