Gastric CancerNCT01486472
S-1-induced Lacrimal Drainage Obstruction
An observational study of Gastric Cancer, run by Seoul National University Bundang Hospital at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastric Cancer
- What is being tested?
- S-1
- How many people
- 200 participants
- Where
- 1 siteSouth Korea
- Study dates
- Nov 2010to Dec 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients receiving S-1 as an adjuvant chemotherapy after radial surgery (D2 dissection) for GC
Who may be able to join
- 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)
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 463-707
Keun-Wook Lee Lee, M.D. & Ph.D., 82-31-787-7009, hmodoctor@hanmail.net
Namju Kim, M.D., 82-31-787-7376, resourceful@hanmail.net
About this study
Official title: Lacrimal Drainage Obstruction in Gastric Cancer Patients Receiving Adjuvant S-1 Chemotherapy: A Prospective Study
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
- Being tested
- S-1
- Keywords
- Adjuvant chemotherapy
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
S-1Drug
Adjuvant S-1 chemotherapy will be performed to GC patients receiving curative D2 gastric surgery
| Study group | Role | What they receive |
|---|---|---|
| GC patients receiving adjuvant S-1 chemotherapy | Not described Receives: Drug: S-1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of LDO
The cumulative incidence of LDO during the 1 year after adjuvant S1 chemotherapy will be analyzed
Measured: The incidence of LDO (1 year)
Secondary outcomes (1)
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2011 (estimated)
- Study startNov 2010
- Primary completionDec 2012 (estimated)
- Study completionDec 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric CancerStudies of the same condition, open and under way.
- More trials run by Seoul National University Bundang HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Bundang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Keun-Wook Lee, Seoul National University Bundang Hospital
- Investigators
- Keun-Wook Lee, M.D. & Ph.D., Principal investigator, Department of Internal Medicine, Seoul National University Bundang HospitalNamju Kim, M.D., Principal investigator, Department of Opthalmology, Seoul National University Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01486472
- Sponsor's protocol ID
- GC-SNUBH-2010-01
- Other IDs
- GC-CTX-01
- Status last verified
- Dec 2011
- First submitted
- 2 Dec 2011
- Last updated
- 7 Dec 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lacrimal Drainage Obstruction in Gastric Cancer Patients Receiving Adjuvant S-1 Chemotherapy: A Prospective Study
- ClinicalTrials.gov ID
- NCT01486472
- Acronym / sponsor ID
- GC-SNUBH-2010-01
- Conditions
- Gastric Cancer
- Keywords
- Adjuvant chemotherapy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Seoul National University Bundang HospitalUniversity, hospital or other
- Study start
- Nov 2010
- Primary completion
- Dec 2012 (estimated)
- Study completion
- Dec 2013 (estimated)
- First posted
- 6 Dec 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| GC patients receiving adjuvant S-1 chemotherapy | – | Drug: S-1 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients receiving S-1 as an adjuvant chemotherapy after radial surgery (D2 dissection) for GC
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (3 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| S-1Adjuvant S-1 chemotherapy will be performed to GC patients receiving curative D2 gastric surgery | Drug | GC patients receiving adjuvant S-1 chemotherapy |
Primary outcome
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
1 secondary outcome
Correlation between the concentration of S-1-related chemical compounds and the developement of LDO
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Keun-Wook Lee, M.D. & Ph.D. principal investigator
Department of Internal Medicine, Seoul National University Bundang Hospital
Namju Kim, M.D. principal investigator
Department of Opthalmology, Seoul National University Bundang Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gastric Cancer, run by Seoul National University Bundang Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Dec 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Keun-Wook Lee, M.D. & Ph.D. (82-31-787-7009, hmodocto@hanmail.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of LDO (time frame: The incidence of LDO (1 year)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Dec 2011.