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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000014558
Receipt No. R000016936
Scientific Title Phase2 study of Nab-Paclitaxel in patients with unresectable or advanced squamous cell lung cancer
Date of disclosure of the study information 2014/07/15
Last modified on 2014/07/15

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Basic information
Public title Phase2 study of Nab-Paclitaxel in patients with unresectable or advanced squamous cell lung cancer
Acronym Phase2 study of Nab-Paclitaxel in patients with unresectable or advanced squamous cell lung cancer
Scientific Title Phase2 study of Nab-Paclitaxel in patients with unresectable or advanced squamous cell lung cancer
Scientific Title:Acronym Phase2 study of Nab-Paclitaxel in patients with unresectable or advanced squamous cell lung cancer
Region
Japan

Condition
Condition squamous cell lung cancer
Classification by specialty
Medicine in general Pneumology Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To assess the efficacy of Nab-paclitaxel as second therapy in patients with unresectable or advanced squamous cell lung cancer.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Disease Control Rate(DCR)
Key secondary outcomes Response Rate(RR), Overall Surivival(OS), Progress Free Survival(PFS), 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 Nab-Paclitaxel
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)Diagnosis as squamous cell lung cancer by histology or cytology 2)Measurable lesion by CT 3)Histoly of 1 regime of chemotherapy 4)Performance Status(ECOG)=0 or 1 5)Predictable more than 3month survival 6)20 years old of age and older 7)Normal bone-marrow function, hepatic function, renal function 8)Normal Cardiac electrogram 9)Written informed consent about transfusion of blood or substance of specific biological origin 10)Written informed consent about enrollment of this clinical trial
Key exclusion criteria 1) Patient with need of procedure for pleural effusion
2) History of hypersensitivity against albumin preparation
3) Patient with need of drainage procedure for cardiac effusion
4) Patient with symptomatic brain metastasis
5) Patient with severe complications.
6) Patients with interstitial pneumonia or pulmonary fibrosis diagnosed by chest X-ray
7) Female Patient in or having a chance or planning of pregnancy or breast feeding,
8) Male patient in planning to impregnate
9) Patient with active multiple cancers.
10) Patients with history of drug hypersensitivity
11) Patinets with histoly of hypersensitivity against Txeane agents include paclitaxel and docetaxel
12) Case which was judged as impossible to perform by physician in charge
Target sample size 27

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Eiji Shimizu
Organization Tottori University Faculty of Medicine
Division name Division of Medical Oncology and Molecular Respirology
Zip code
Address NIshimachi36-1, Yonago, Tottori, Japan
TEL 0859-38-6537
Email eiji@med.tottori-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Haruhiko Makino
Organization Tottori University Faculty of Medicine
Division name Division of Medical Oncology and Molecular Respirology
Zip code
Address NIshimachi36-1, Yonago, Tottori, Japan
TEL 0859-38-6537
Homepage URL
Email hmakino@med.tottori-u.ac.jp

Sponsor
Institute Tottori University Faculty of Medicine
Institute
Department

Funding Source
Organization Tottori University Faculty of Medicine, Division of Medical Oncology and Molecular Respirology
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
2014 Year 07 Month 15 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 Enrolling by invitation
Date of protocol fixation
2013 Year 06 Month 17 Day
Date of IRB
Anticipated trial start date
2013 Year 07 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
2014 Year 07 Month 15 Day
Last modified on
2014 Year 07 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016936

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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