A Study of TS-1 Plus Cisplatin in Patients With Advanced Non-small-cell Lung Cancer

Not Applicable

Completed

• Conditions: Non-small-cell Lung Cancer (NSCLC)
• Interventions: Drug: TS-1/Cisplatin

• Registration Number: NCT01874678
• Lead Sponsor: TTY Biopharm

Brief Summary

Objectives:

1. 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

2. 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

Detailed Description

Not available

Study Timeline

• Study Start: 2011-03
• Study First Submitted: 2013-06-04
• Study First Submitted QC: 2013-06-06
• Study First Posted: 2013-06-11
• Primary Completion: 2015-12
• Study Completion: 2015-12
• Status Verified: 2016-01
• Last Update Submitted: 2016-01-10
• Last Update Posted: 2016-01-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

Inclusion Criteria

To be eligible for inclusion, each subject must fulfill all of the following criteria:

1. histologically or cytologically confirmed non-small cell bronchogenic carcinoma
2. Stage IIIb or IV disease
3. 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
4. performance status of ECOG 0, 1
5. age between 20 and 74 years at registration
6. life expectancy of at least 12 weeks
7. ability to take the oral study medication (TS-1)
8. 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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
TS-1/Cisplatin	TS-1/Cisplatin	single arm

Primary Outcome Measures

Name	Time	Method
overall response rate	2 year	To assess overall response rate

Secondary Outcome Measures

Name	Time	Method
To assess progression free survival To assess overall survival To bridge the safety profile by assessing the toxicities and tolerability	2 year	To assess progression free survival To assess overall survival To bridge the safety profile by assessing the toxicities and tolerability

Trial Locations

Locations (5)

Taichung Veterans General Hospital; 🇨🇳 Taichung, Taiwan

China Medical University Hospital; 🇨🇳 Taichung, Taiwan

Taipei Veterans General Hospital; 🇨🇳 Taipei, Taiwan

Dalin Tzu Chi General Hospital; 🇨🇳 Chiayi, Taiwan

E-Da Hospital; 🇨🇳 Kaohsiung, Taiwan