S-1-induced Lacrimal Drainage Obstruction

Gastric Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01486472
• Other study ID #: GC-SNUBH-2010-01
• Secondary ID: GC-CTX-01
• Status: Recruiting
• Phase: N/A
• First received: December 2, 2011
• Last updated: December 6, 2011
• Start date: November 2010
• Est. completion date: December 2013

Study information

• Verified date: December 2011
• Source: Seoul National University Bundang Hospital
• Contact: Keun-Wook Lee, M.D. & Ph.D.
• Phone: 82-31-787-7009
• Email: hmodocto[@]hanmail.net
• Is FDA regulated: No
• Health authority: South Korea: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 2013
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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)

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Gastric Cancer
• Stomach Neoplasms

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam	Gyeonggi-do

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Bundang Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No
Secondary	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		No