Clinical trial NCT01874678: 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
Overall status: COMPLETED
Phase: NA
Conditions: Non-small-cell Lung Cancer (NSCLC)
Lead sponsor: TTY Biopharm
Sponsor class: INDUSTRY
First posted: 2013-06-11
Enrollment: 45
Sex: ALL
Minimum age (years): 20
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


Eligibility criteria: 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.

Primary outcomes:
measure: overall response rate
timeFrame: 2 year
Secondary outcomes:
measure: To assess progression free survival To assess overall survival To bridge the safety profile by assessing the toxicities and tolerability
timeFrame: 2 year
Other outcomes:
Locations:
city: Chiayi
country: Taiwan
facility: Dalin Tzu Chi General Hospital
city: Kaohsiung
country: Taiwan
facility: E-Da Hospital
city: Taichung
country: Taiwan
facility: China Medical University Hospital
city: Taichung
country: Taiwan
facility: Taichung Veterans General Hospital
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospital
Study officials:
References:
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.
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.