Ignite Creation Date:
2024-05-06 @ 12:05 AM
Last Modification Date:
2024-10-26 @ 10:44 AM
Study NCT ID:
NCT01486472
Status:
UNKNOWN
Last Update Posted:
2011-12-07
First Post:
2011-12-02
Brief Title:
S-1-induced Lacrimal Drainage Obstruction
Sponsor:
Seoul National University Bundang Hospital
Organization:
Seoul National University Bundang Hospital
Study Overview
Official Title:
Lacrimal Drainage Obstruction in Gastric Cancer Patients Receiving Adjuvant S-1 Chemotherapy A Prospective Study
Status:
UNKNOWN
Status Verified Date:
2011-12
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 1520 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
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 1520 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| GC-CTX-01 | OTHER | SNUBH | None |