S-1-induced Lacrimal Drainage Obstruction

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

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 Overview

• Status: Unknown
• Conditions: Gastric Cancer
• Intervention / Treatment: Drug: S-1

• Study Type: Observational
• Enrollment (Anticipated): 200

Contacts and Locations

Study Locations

• Korea, Republic of
  • Gyeonggi-do
    • Seongnam, Gyeonggi-do, Korea, Republic of, 463-707
      • Recruiting
      • Seoul National University Bundang Hospital
      • Contact: Namju Kim, M.D.; Phone Number: 82-31-787-7376; Email: resourceful@hanmail.net
      • Contact: Keun-Wook Lee Lee, M.D. & Ph.D.; Phone Number: 82-31-787-7009; Email: hmodoctor@hanmail.net

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients receiving S-1 as an adjuvant chemotherapy after radial surgery (D2 dissection) for GC

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
GC patients receiving adjuvant S-1 chemotherapy	Drug: S-1; Adjuvant S-1 chemotherapy will be performed to GC patients receiving curative D2 gastric surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)

Secondary Outcome Measures

Outcome Measure	Measure Description
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

Collaborators and Investigators

• Sponsor: Seoul National University Bundang Hospital
• Investigators: 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

Study record dates

Study Major Dates

• Study Start: November 1, 2010
• Primary Completion (Anticipated): December 1, 2012
• Study Completion (Anticipated): December 1, 2013

Study Registration Dates

• First Submitted: December 2, 2011
• First Submitted That Met QC Criteria: December 5, 2011
• First Posted (Estimate): December 6, 2011

Study Record Updates

• Last Update Posted (Estimate): December 7, 2011
• Last Update Submitted That Met QC Criteria: December 6, 2011
• Last Verified: December 1, 2011

More Information

Terms related to this study

• Keywords: Adjuvant chemotherapy
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Stomach Diseases; Stomach Neoplasms
• Other Study ID Numbers: GC-SNUBH-2010-01; GC-CTX-01 (Other Identifier: SNUBH)