We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

S-1-induced Lacrimal Drainage Obstruction

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified December 2011 by Keun-Wook Lee, Seoul National University Bundang Hospital.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01486472
First Posted: December 6, 2011
Last Update Posted: December 7, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Keun-Wook Lee, Seoul National University Bundang Hospital
  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:


Further study details as provided by Keun-Wook Lee, Seoul National University Bundang Hospital:

Primary Outcome Measures:
  • The incidence of LDO [ Time Frame: The incidence of LDO (1 year) ]
    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
    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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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 ( Other Identifier: SNUBH )
First Submitted: December 2, 2011
First Posted: December 6, 2011
Last Update Posted: December 7, 2011
Last Verified: December 2011

Keywords provided by Keun-Wook Lee, 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