Concentration of S-1 Metabolites in Tear and Plasma of Patients Receiving TS-1

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-12-31

Study Completion Date

2013-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

S-1 has been also shown to be an effective drug for palliative chemotherapy in Eastern and Western GC patients. Recently, some case and small-sized studies have been reported on lacrimal drainage obstruction(LDO)caused by S-1.Suggested mechanism of LDO involves direct secretion of S-1 into the tear; thus the concentration of S-1 metabolite in tear is expected to be high in patients who developed LDO than in patients without LDO. We investigate the concentration of S-1 and its metabolites in tear and plasma and find out its correlation with side effects such as LDO. These results will also help us identify patients who are at high risk of developing S-1-associated side effects.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Pilot Trial of Oral Topotecan for the Treatment of Refractory Advanced Solid Neoplasms Expressing HIF-1a

NCT00117013

Neoplasms

COMPLETED PHASE1

Study of Cytoreductive Surgery and Hyperthermic Intrathoracic Pleural Chemotherapy (HITC) With Escalating Doses for Children and Adolescents With Unilateral Pleural Malignancy

NCT01998529

Lung Cancer

COMPLETED PHASE1

1-Methyl-D-Tryptophan in Treating Patients With Metastatic or Refractory Solid Tumors That Cannot Be Removed By Surgery

NCT00567931

Unspecified Adult Solid Tumor, Protocol Specific

COMPLETED PHASE1

Docetaxel in Treating Patients With Solid Tumors and Abnormal Liver Function

NCT00002901

Breast Cancer Head and Neck Cancer Lung Cancer +2 more

COMPLETED PHASE1

A Study to Investigate the Effect of Food on Oral LBH589 Absorption in Patients With Advanced Solid Tumors

NCT00570284

Cancer

COMPLETED PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

1. S-1 metabolites concentration in plasma

1. factors affecting plasma concentration

* surgery subtype
* serum creatinine
2. systemic adverse effects of S-1 and its correlation with plasma S-1 metabolites concentration

* enteritis
* fatigue
2. S-1 metabolites concentration in tears

1. correlation of tear concentration with plasma concentration
2. lacrimal drainage obstruction caused by S-1 administration, and its correlation with tear S-1 metabolites concentration
3. lacrimal drainage obstruction caused by S-1 administration, and its correlation with plasma S-1 metabolites concentration

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Gastric Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Patients who received radical surgery for gastric cancer
* Patients who receiving S-1 adjuvant chemotherapy
* Patients who administrated S-1 for more than 7 days