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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000005077
Receipt No. R000006037
Scientific Title Phase II Study of Docetaxel+Bevacizumab with non-squamous non-small cell lung cancer for patients pretreated with chemotherapy
Date of disclosure of the study information 2011/02/14
Last modified on 2015/08/27

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Basic information
Public title Phase II Study of Docetaxel+Bevacizumab with non-squamous non-small cell lung cancer for patients pretreated with chemotherapy
Acronym Phase II Study of Docetaxel+Bevacizumab with non-squamous non-small cell lung cancer for patients pretreated with chemotherapy
Scientific Title Phase II Study of Docetaxel+Bevacizumab with non-squamous non-small cell lung cancer for patients pretreated with chemotherapy
Scientific Title:Acronym Phase II Study of Docetaxel+Bevacizumab with non-squamous non-small cell lung cancer for patients pretreated with chemotherapy
Region
Japan

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

Objectives
Narrative objectives1 To evaluate the efficacy and safety of the combination of docetaxel and bevacizumab with non-squamous non-small cell lung cancer for patients pretreated with chemotherapy.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes Progression free survival
Key secondary outcomes Response rate
Overall survival
Safety
PFS,RR,OS,DCR(harboring EGFR mutation or not)


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 Docetaxel+bevacizumab
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.Histologically confirmed StageIIIB/IV non-small-cell lung cancer and non-squamous cell carcinoma.

2.Patients who have previously treated one chemotherapy regimen (without docetaxel and bevacizumab.).

3.With one or more measurable disease based on Response Evaluation Criteria In Solid Tumors (RECIST) ver.1.1.

4.No chemotherapy within 21days
No operation or radiotherapy within 56 days
No pleurodesis, pleural drainage etc. within 28 days

5.Age20<=

6.Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2.

7.Adequate function of vital organs, including normal hematopoietic function, normal liver function and normal renal function as evidenced by the following data:

8.A life expectancy of more than 3 months.

9.All patients provided written informed consent before initiation of study-related procedures.
Key exclusion criteria 1)Symptomatic Brain metastasis or expected bleeding.
2) history of active double cancer within 5 years.
3) Severe infection
4) History of hemoptysis with 2.5mL or more.
5) Continued bloody phlegm.
6) Receiving anticoagulant drug(including Aspirin over 325mg/day).
7) Perforation of the digestive tract or history of the perforation of the digestive tract within the past one year.
8) Severe comorbidity (heart failure Tendency to hemorrhages uncontrollable hypertension, uncontrollable diabetes, etc)
9) Arterial thromboembolism and Venous thromboembolism within the past one year.
10)Interstitial pneumonia or pulmonary fibrosis detectable on X ray.
11) Neuropathy or edema
12) History of hypersensitivity reaction to drugs formulated with polysorbate.
13) Planning of surgery or thoracic radiotherapy during the trial.
14) Major surgical procedure
15) With a history of drug sensitivity.
16) Pregnant or lactating women or those who declined contraception.
17) Any other medical condition that makes the patient unsuitable for inclusion in the study according to the opinion of the investigator.
Target sample size 22

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kiyoshi Mori
Organization Tochigi Cancer Center
Division name Division of Thoracic Oncology
Zip code
Address 4-9-13 Yonan, Utsunomiya City, Tochigi, 320-0834
TEL 028-658-5151
Email kmori@tcc.pref.tochigi.lg.jp

Public contact
Name of contact person
1st name
Middle name
Last name Takashi Kasai
Organization Tochigi Cancer Center
Division name Division of Thoracic Oncology
Zip code
Address 4-9-13 Yonan, Utsunomiya City, Tochigi, 320-0834
TEL 028-658-5151
Homepage URL
Email takasai@tcc.pref.tochigi.lg.jp

Sponsor
Institute Tochigi Cancer Center
Institute
Department

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

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

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

Other administrative information
Date of disclosure of the study information
2011 Year 02 Month 14 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 Completed
Date of protocol fixation
2011 Year 01 Month 10 Day
Date of IRB
Anticipated trial start date
2011 Year 01 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2011 Year 02 Month 14 Day
Last modified on
2015 Year 08 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006037

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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