UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Phase II study of S-1/paclitaxel combination therapy in patients with previously treated non-small cell lung cancer
Title of the study (Brief title)	Phase II study of S-1/paclitaxel combination therapy in patients with previously treated non-small cell lung cancer
Region	Japan

Condition
Condition	non-small cell lung cancer
Classification by specialty	Pneumology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	This trial evaluated the efficacy and toxicity of S-1/paclitaxel combination therapy in patients with previously treated non-small cell lung cancer (NSCLC).
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase	Phase II

Assessment
Primary outcomes	Overall response rate
Key secondary outcomes	Progression-free survival Overall survival safety

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	S1 is administered orally twice daily for 14 days a day, according to the body surface area, followed by 7 days off. PTX 80 mg / m 2 is administered on Day 1, 8 by drip infusion. One cycle is 21 days.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1) A case in which definitive diagnosis of non-small cell lung cancer was obtained by histology or cytology 2) Cases with measurable lesions 3) Patients with a history of chemotherapy treatment containing 1 platinum regimen over 1 regimen (treatment history of surgical therapy and radiotherapy is not limited) 4) Cases with 4 weeks or more have passed since the end of previous chemotherapy 5) Case of over 20 years old 6) Case of Performance Status 0-1 of ECOG 7) Cases with sufficient bone marrow function and organ function 8) Cases in which survival for more than 2 months can be expected 9) Cases with oral administration 10) Case informed consent obtained document from patient himself
Key exclusion criteria	1: Cases with serious complications Interstitial pneumonia Serious heart disease diabetes which is difficult to control Serious infectious diseases 2: Cases with other active organs and overlapping cancers 3: Patients with a history of severe hypersensitivity 4: Case in which flucytosine is being administered 5) Cases with a history of alcohol hypersensitivity
Target sample size	45

Research contact person
Name of lead principal investigator	Yoshinobu Iwasaki
Organization	Kyoto Prefectural University of Medicine
Division name	Department of Pulmonary Medicine
Address	Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto 602-8566, Japan.
TEL	075-251-5513
Email	c1981311@koto.kpu-m.ac.jp

Public contact
Name of contact person	Yusuke Chihara
Organization	Kyoto Prefectural University of Medicine
Division name	Department of Pulmonary Medicine
Address	Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto 602-8566, Japan.
TEL	075-251-5513
Homepage URL
Email	c1981311@koto.kpu-m.ac.jp

Sponsor
Institute	Kyoto Prefectural University of Medicine
Institute
Department

Funding Source
Organization	Kyoto Prefectural University of Medicine
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2019 Year 02 Month 08 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2011 Year 11 Month 12 Day
Anticipated trial start date	2011 Year 11 Month 12 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2019 Year 02 Month 08 Day
Last modified on	2019 Year 02 Month 08 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040750