UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014558 |
|---|---|
| Receipt number | 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 11:19:52 |
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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
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
hmakino@med.tottori-u.ac.jp
Sponsor or person
Institute
Tottori University Faculty of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016936
