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

Non-small-cell Lung Cancer (NSCLC) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01874678
• Other study ID #: TTYTG0904
• Status: Completed
• Phase: N/A
• First received: June 4, 2013
• Last updated: January 10, 2016
• Start date: March 2011
• Est. completion date: December 2015

Study information

• Verified date: January 2016
• Source: TTY Biopharm
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Taiwan Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 74 Years

Eligibility

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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-small-cell Lung Cancer (NSCLC)

Intervention

Drug:
• TS-1/Cisplatin

Locations

Country	Name	City	State
Taiwan	Dalin Tzu Chi General Hospital	Chiayi
Taiwan	E-Da Hospital	Kaohsiung
Taiwan	China Medical University Hospital	Taichung
Taiwan	Taichung Veterans General Hospital	Taichung
Taiwan	Taipei Veterans General Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
TTY Biopharm

Country where clinical trial is conducted

Taiwan, 

References & Publications (2)

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. — View 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-naïve 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	overall response rate	To assess overall response rate	2 year	No
Secondary	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	2 year	Yes

External Links

•   TFDA