S-1-induced Lacrimal Drainage Obstruction

NCT01486472 | Unknown

• 2 other identifiers: GC-SNUBH-2010-01GC-CTX-01
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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

Gastric Cancer

Keywords

Adjuvant chemotherapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Correlation between the concentration of S-1-related chemical compounds and the developement of LDO

Study Arms (1)

GC patients receiving adjuvant S-1 chemotherapy

Drug: S-1

Interventions

S-1 DRUG

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

GC patients receiving adjuvant S-1 chemotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• Seoul National University Bundang Hospital: lead

Study Sites (1)

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 463-707, South Korea

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Plasma Tears

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

S 1 (combination)

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Keun-Wook Lee, M.D. & Ph.D.

CONTACT

82-31-787-7009; hmodocto@hanmail.net

Namju Kim, M.D.

CONTACT

82-31-787-7376; resourceful@hanmail.net

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical professor

Study Record Dates

• First Submitted: December 2, 2011
• First Posted: December 6, 2011
• Study Start: November 1, 2010
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2013
• Last Updated: December 7, 2011

Record last verified: 2011-12

Locations

KR (1)