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S-1-induced Lacrimal Drainage Obstruction

This study is currently recruiting participants.
Verified December 2011 by Seoul National University Bundang Hospital
Sponsor:
Information provided by (Responsible Party):
Keun-Wook Lee, Seoul National University Bundang Hospital
ClinicalTrials.gov Identifier:
NCT01486472
First received: December 2, 2011
Last updated: December 6, 2011
Last verified: December 2011
History of Changes
  Purpose

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 Intervention
Gastric Cancer
 Drug: S-1

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Lacrimal Drainage Obstruction in Gastric Cancer Patients Receiving Adjuvant S-1 Chemotherapy: A Prospective Study

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Seoul National University Bundang Hospital:

Primary Outcome Measures:
  • The incidence of LDO [ Time Frame: The incidence of LDO (1 year) ] [ Designated as safety issue: No ]
    The cumulative incidence of LDO during the 1 year after adjuvant S1 chemotherapy will be analyzed


Secondary Outcome Measures:
  • Correlation between the concentration of S-1-related chemical compounds and the developement of LDO [ Designated as safety issue: No ]
    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


Biospecimen Retention:   Samples Without DNA

Plasma Tears


Estimated Enrollment: 200
Study Start Date: November 2010
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01486472

Contacts
Contact: Keun-Wook Lee, M.D. & Ph.D. 82-31-787-7009 hmodocto@hanmail.net
Contact: Namju Kim, M.D. 82-31-787-7376 resourceful@hanmail.net

Locations
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     hmodoctor@hanmail.net    
Contact: Namju Kim, M.D.     82-31-787-7376     resourceful@hanmail.net    
Sponsors and Collaborators
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
  More Information

No publications provided

Responsible Party: Keun-Wook Lee, Clinical professor, Seoul National University Bundang Hospital
ClinicalTrials.gov Identifier: NCT01486472     History of Changes
Other Study ID Numbers: GC-SNUBH-2010-01, GC-CTX-01
Study First Received: December 2, 2011
Last Updated: December 6, 2011
Health Authority: South Korea: Institutional Review Board

Keywords provided by Seoul National University Bundang Hospital:
Adjuvant chemotherapy

Additional relevant MeSH terms:
Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
 Gastrointestinal Diseases
Stomach Diseases
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 21, 2013