- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01874678
A Study of TS-1 Plus Cisplatin in Patients With Advanced Non-small-cell Lung Cancer
Objectives:
Primary Objective:
To bridge the data of efficacy in term of overall response rate of TS-1 plus cisplatin in Taiwanese advanced NSCLC patients from that gained from Japanese population
- Secondary Objectives:
A. To assess progression free survival B. To assess overall survival C. To bridge the safety profile by assessing the toxicities and tolerability
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Chiayi, Taiwan
- Dalin Tzu Chi General Hospital
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Kaohsiung, Taiwan
- E-Da Hospital
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Taichung, Taiwan
- China Medical University Hospital
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Taichung, Taiwan
- Taichung Veterans General Hospital
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Taipei, Taiwan
- Taipei Veterans General Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
To be eligible for inclusion, each subject must fulfill all of the following criteria:
- histologically or cytologically confirmed non-small cell bronchogenic carcinoma
- Stage IIIb or IV disease
- presence of at least one measurable disease which is defined as lesion that can be measured in at least 1 dimension as ≥20 mm with conventional CT/MRI or ≥10 mm with spiral CT scan
- performance status of ECOG 0, 1
- age between 20 and 74 years at registration
- life expectancy of at least 12 weeks
- ability to take the oral study medication (TS-1)
- voluntarily signed the written informed consent form.
Exclusion Criteria:
- other malignancy with the exception of curative treated non-melanoma skin cancer or cervical carcinoma in situ within 5 years prior to the entry of study
- previously received chemotherapy or therapy with systemic anti-tumor effect
- significant co-morbid medical conditions, including, but not limited to , heart failure, renal failure, hepatic failure, hemorrhagic peptic ulcer, mechanical or paralytic ileus, or poorly controlled diabetes
- fertile women of child-bearing potential unless using a reliable and appropriate contraceptive method throughout the treatment period and for three months following cessation of treatment
- Presence of mental disease or psychotic manifestation
- Participation in another clinical trial with any investigational drug within 30 days prior to entry
- judged ineligible by physicians for participation in the study due to safety concern.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: TS-1/Cisplatin
single arm
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
overall response rate
Time Frame: 2 year
|
To assess overall response rate
|
2 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
To assess progression free survival To assess overall survival To bridge the safety profile by assessing the toxicities and tolerability
Time Frame: 2 year
|
To assess progression free survival To assess overall survival To bridge the safety profile by assessing the toxicities and tolerability
|
2 year
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Okamoto I, Yoshioka H, Morita S, Ando M, Takeda K, Seto T, Yamamoto N, Saka H, Asami K, Hirashima T, Kudoh S, Satouchi M, Ikeda N, Iwamoto Y, Sawa T, Miyazaki M, Tamura K, Kurata T, Fukuoka M, Nakagawa K. Phase III trial comparing oral S-1 plus carboplatin with paclitaxel plus carboplatin in chemotherapy-naive patients with advanced non-small-cell lung cancer: results of a west Japan oncology group study. J Clin Oncol. 2010 Dec 20;28(36):5240-6. doi: 10.1200/JCO.2010.31.0326. Epub 2010 Nov 15.
- Ichinose Y, Yoshimori K, Sakai H, Nakai Y, Sugiura T, Kawahara M, Niitani H. S-1 plus cisplatin combination chemotherapy in patients with advanced non-small cell lung cancer: a multi-institutional phase II trial. Clin Cancer Res. 2004 Dec 1;10(23):7860-4. doi: 10.1158/1078-0432.CCR-04-1200.
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- TTYTG0904
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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