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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000009872
Receipt No. R000011568
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
Date of disclosure of the study information 2013/01/31
Last modified on 2019/03/30

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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
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
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/ctr_e/ctr_view.cgi?recptno=R000011568

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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