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Recruitment status Terminated
Unique ID issued by UMIN UMIN000009871
Receipt No. R000011567
Scientific Title Phase II study of continuation maintenance by use of TS1 and Bevacizumab after induction chemotherapy of cisplatin and TS1 pulse bevacizumab in patients with Stage IIIB / IV non-squamous and non-small cell lung cancer - Research of efficacy predictive biomarker
Date of disclosure of the study information 2013/01/31
Last modified on 2018/09/29

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

Condition
Condition Non-small and non-squamous 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 pulse bevacizumab followed by TS1 and bevacizumab in patients with Stage IIIB / IV non-squamous and 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 pulse bevacizumab followed by TS1 and bevacizumab

the other trial of same chemotherapy without 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 I) Eligibility criteria for Pre-registration
1) Histologically or cytologically proven non-squamous and 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 can start within 6 weeks after start of TS1 of last cycle.
Key exclusion criteria 1) Patients with squamous cell lung cancer.
2) History of allergic reaction for agents of present treatment
3) Severe myelosupperssion, renal dysfunction or hepatic dysfunction
4) Patients received post-operation adjuvant therapy within 6 months.
5) Active concomitant malignancy except carcinoma in situ, intramucosal carcinoma or cancer with more than 5 year disease free
6) 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
7) Diarrhea more than and equal to grade 2
8) Active infection more than and equal to grade 2
9) Massive pleural effusion, peritoneal effusion or cardiac effusion required for tube drainage
10) Symptomatic brain metastasis but eligible for controlled brain metastases
11) Patients required for continuing steroid therapy
12) A history of significant hemoptysis (> 2.5 mL red blood per episode) within 3 months before enrolment
13) History of thrombosis
14) Surgical biopsy or treatment within 4 weeks
15) Under treatment of oral coagulant or intravenous coagulant
16) Bleeding tendency, blood coagulation disorder
17) Other ineligible for bevacizumab
18) Pregnant status or lactation
19) Uncontrolled psychiatric disease
20) Other ineligible status judged by medical oncologist.
Target sample size 33

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yuichiro Takeda
Organization National Center for Global health and Medicine
Division name Department of Respiratory Medicine
Zip code
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
Middle name
Last name Yuichiro Takeda
Organization National Center for Global health and Medicine
Division name Department of Respiratory Medicine
Zip code
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
Address
Tel
Email

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
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
Anticipated trial start date
2012 Year 12 Month 17 Day
Last follow-up date
2018 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2013 Year 01 Month 25 Day
Last modified on
2018 Year 09 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011567

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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