Back to resultsA Study of TS-1 Plus Cisplatin in Patients With Advanced Non-small-cell Lung Cancer
Primary Purpose
Non-small-cell Lung Cancer (NSCLC)
Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
TS-1/Cisplatin
Sponsored by
About this trial
This is an interventional treatment trial for Non-small-cell Lung Cancer (NSCLC)
Eligibility Criteria
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.
Sites / Locations
- Dalin Tzu Chi General Hospital
- E-Da Hospital
- China Medical University Hospital
- Taichung Veterans General Hospital
- Taipei Veterans General Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
TS-1/Cisplatin
Arm Description
single arm
Outcomes
Primary Outcome Measures
overall response rate
To assess overall response rate
Secondary Outcome Measures
To assess progression free survival To assess overall survival To bridge the safety profile by assessing the toxicities and tolerability
To assess progression free survival To assess overall survival To bridge the safety profile by assessing the toxicities and tolerability
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01874678
Brief Title
A Study of TS-1 Plus Cisplatin in Patients With Advanced Non-small-cell Lung Cancer
Official Title
A Study of TS-1 Plus Cisplatin in Patients With Advanced Non-small-cell Lung Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
March 2011 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
December 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
TTY Biopharm
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-small-cell Lung Cancer (NSCLC)
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
45 (Actual)
8. Arms, Groups, and Interventions
Arm Title
TS-1/Cisplatin
Arm Type
Experimental
Arm Description
single arm
Intervention Type
Drug
Intervention Name(s)
TS-1/Cisplatin
Primary Outcome Measure Information:
Title
overall response rate
Description
To assess overall response rate
Time Frame
2 year
Secondary Outcome Measure Information:
Title
To assess progression free survival To assess overall survival To bridge the safety profile by assessing the toxicities and tolerability
Description
To assess progression free survival To assess overall survival To bridge the safety profile by assessing the toxicities and tolerability
Time Frame
2 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
74 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Dalin Tzu Chi General Hospital
City
Chiayi
Country
Taiwan
Facility Name
E-Da Hospital
City
Kaohsiung
Country
Taiwan
Facility Name
China Medical University Hospital
City
Taichung
Country
Taiwan
Facility Name
Taichung Veterans General Hospital
City
Taichung
Country
Taiwan
Facility Name
Taipei Veterans General Hospital
City
Taipei
Country
Taiwan
12. IPD Sharing Statement
Citations:
PubMed Identifier
21079147
Citation
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.
Results Reference
background
PubMed Identifier
15585618
Citation
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.
Results Reference
background
Links:
URL
http://www.fda.gov.tw/TC/index.aspx
Description
TFDA
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A Study of TS-1 Plus Cisplatin in Patients With Advanced Non-small-cell Lung Cancer
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