UMIN-CTR Clinical Trial

Basic information
Public title	Phase II study of continuation maintenance by use of TS1 after induction chemotherapy of cisplatin and TS1 in patients with Stage IIIB / IV non-small cell lung cancer-Research of efficacy predictive biomarker
Acronym	Phase II of cisplatin and TS1 followed by TS1
Scientific Title	Phase II study of continuation maintenance by use of TS1 after induction chemotherapy of cisplatin and TS1 in patients with Stage IIIB / IV non-small cell lung cancer-Research of efficacy predictive biomarker
Scientific Title:Acronym	Phase II of cisplatin and TS1 followed by TS1
Region	Japan

Condition
Condition	Non-small cell lung cancer
Classification by specialty	Pneumology Hematology and clinical oncology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate efficacy and safety of cisplatin and TS1 followed by TS1 in patients with Stage IIIB / IV non-small cell lung cancer
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Explanatory
Developmental phase	Phase II

Assessment
Primary outcomes	Progression free survival from the beginning of maintenance therapy
Key secondary outcomes	Response rate by RECIST, Overall survival, Time to treatment failure, Adverse events, Quality of life, Efficacy predictive factors (Thymidylate synthase, Dihydoropyrimidine dehydrogenase, others)

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	Cisplatin and TS1 followed by TS1 the other trial of same chemotherapy with bevacizumab at same time
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	75 years-old >=
Gender	Male and Female
Key inclusion criteria	Eligibility criteria for Pre-registration 1) Histologically or cytologically proven non-small cell lung cancer 2) Stage IIIB/IV without indication for radical thoracic irradiation or recurrence after surgical treatment 3) Naive treatment of cytotoxic chemotherapy. Treatments below are acceptable for pre-registaration a) Palliative Irradiation except primary tumor of lung more than 2 weeks ago b)First line treatment by epidermal growth factor receptor-tyrosine kinase inhibitors more than 2 weeks ago c)post-operation adjuvant therapy more than 6 months. 4)Eastern Cooperative Oncology Group performance status of 0-1 5)Age; > or = 20 years and < 75 years 6) Tumor has the evaluable lesion. 7) capable of oral intake 8) Adequate organ function, Adequate organ function within 2 weeks a) Leukocyte count; > or = 3,000/mm3 b) Neutrophil count; > or = 1,500/mm3 c) Platelet count; > or = 100,000/mm3 d) Hemoglobin concentration; > or = 10.0g/dl e) Total bilirubin level; < or = 2.0 mg/dl f) Aspartate aminotransferse and alanine aminotransferase levels; < or = 100 IU/L g) PaO2; > or = 60 Torr or SpO2; > or = 90% at room air h) Creatinine clearance; > or = 60mL/min 9) Estimating Survival more than 12 weeks 10)Written informed consent II)Eligibility criteria for registration 1) More than 2 cycles of induction chemotherapy 2) Response criteria of induction chemotherapy achieved more than and equal to SD. 3) Maintenance start within 6 weeks after start of TS1 of last cycle.
Key exclusion criteria	1) History of allergic reaction for agents of present treatment 2) Severe myelosupperssion, renal dysfunction or hepatic dysfunction 3) Patients received post-operation adjuvant therapy within 6 months. 4) Active concomitant malignancy except carcinoma in situ, intramucosal carcinoma or cancer with more than 5 year disease free 5) Significant comorbid disease such as paresis of intestine, ileus, interstitial pneumonia, lung fibrosis, uncontrolled diabetes mellitus, cardiac failure, renal failure, hepatic failure, active gastrointestinal ulcer, myocardial infarction and angina pectoris within 6 months, other uncontrolled disease 6) Diarrhea more than and equal to grade 2 7) Active infection more than and equal to grade 2 8) Massive pleural effusion, peritoneal effusion or cardiac effusion required for tube drainage 9) Symptomatic brain metastasis but eligible for controlled brain metastases 10) Patients required for continuing steroid therapy 11) Pregnant status or lactation 12) Uncontrolled psychiatric disease 13) Other ineligible status judged by medical oncologist.
Target sample size	68

Research contact person
Last name of lead principal investigator	1st name Yuichiro Middle name Last name Takeda
Organization	National Center for Global health and Medicine
Division name	Department of Respiratory Medicine
Zip code	162-865
Address	1-21-1 Toyama, Shinjuku-ku, Tokyo, 162-8655, Japan
TEL	03-3202-7181
Email	ytakeda@hosp.ncgm.go.jp

Public contact
1st name of contact person	1st name Yuichiro Middle name Last name Takeda
Organization	National Center for Global health and Medicine
Division name	Department of Respiratory Medicine
Zip code	162-8655
Address	1-21-1 Toyama, Shinjuku-ku, Tokyo, 162-8655, Japan
TEL	03-3202-7181
Homepage URL
Email	ytakeda@hosp.ncgm.go.jp

Sponsor
Institute	Department of Respiratory Medicine National Center for Global health and Medicine
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization	None

Other related organizations
Co-sponsor	None
Name of secondary funder(s)	None

IRB Contact (For public release)
Organization	Center for Clinical sciences, National Center for Global health and Medicine
Address	1-21-1 Toyama, Shinjuku-ku, Tokyo, 162-8655, Japan
Tel	03-3202-7181
Email	rinrijim@hosp.ncgm.go.jp

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	国立国際医療研究センター病院（東京都）

Other administrative information
Date of disclosure of the study information	2013 Year 01 Month 31 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled	14
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Terminated
Date of protocol fixation	2012 Year 10 Month 17 Day
Date of IRB	2012 Year 10 Month 17 Day
Anticipated trial start date	2012 Year 12 Month 10 Day
Last follow-up date	2019 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	This study will terminate at March 31, 2019 because of forced termination based on the clinical study law in Japan.

Management information
Registered date	2013 Year 01 Month 25 Day
Last modified on	2019 Year 03 Month 30 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000011568