Not provided
Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| GC-CTX-01 | Other Identifier | SNUBH |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GC patients receiving adjuvant S-1 chemotherapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| S-1 | Drug | Adjuvant S-1 chemotherapy will be performed to GC patients receiving curative D2 gastric surgery |
|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Patients receiving S-1 as an adjuvant chemotherapy after radial surgery (D2 dissection) for GC
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| 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 |
| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Bundang Hospital | Recruiting | Seongnam-si | Gyeonggi-do | 463-707 | South Korea |
Not provided
| ID | Term |
|---|---|
| D013274 | Stomach Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
Not provided
Not provided
| ID | Term |
|---|---|
| C079198 | S 1 (combination) |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Plasma Tears
| D004066 |
| Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |