UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011776 |
|---|---|
| Receipt number | R000013617 |
| Scientific Title | A phase I/II study of weekly nab-Paclitaxel/Cisplatin in chemotherapy-naive patients with advanced non-small-cell lung cancer |
| Date of disclosure of the study information | 2013/09/17 |
| Last modified on | 2018/03/16 16:39:50 |
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Basic information
Public title
A phase I/II study of weekly nab-Paclitaxel/Cisplatin in chemotherapy-naive patients with advanced non-small-cell lung cancer
Acronym
A phase I/II study of weekly nab-Paclitaxel/Cisplatin in NSCLC
Scientific Title
A phase I/II study of weekly nab-Paclitaxel/Cisplatin in chemotherapy-naive patients with advanced non-small-cell lung cancer
Scientific Title:Acronym
A phase I/II study of weekly nab-Paclitaxel/Cisplatin in NSCLC
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 feasibility and efficacy of nab-paclitaxel and cisplatin in chemotherapy-naive patients with advanced non-small-cell lung cancer.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase I,II
Assessment
Primary outcomes
objective response rate
Key secondary outcomes
progression free survival, overall survival, toxicity
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
Level 0; nab-paclitaxel 80mg/m2, day 1,8,15 cisplatin 60mg/m2 day 1 every 4 weeks
Level 1; nab-paclitaxel 80mg/m2, day 1,8,15 cisplatin 75mg/m2 day 1 every 4 weeks
Level 2; nab-paclitaxel 100mg/m2, day 1,8,15 cisplatin 75mg/m2 day 1 every 4 weeks
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 or cytologically proven non-squamous non-small cell lung cancer
2)Non-small cell lung cancer with stage IIIB,stage IV (UICC-7) or recurrent disease after surgery
3)EGFR mutation negative, ALK rearrangement negative, other driver oncogenes negative
4)Age: 20- years old
5)ECOG PS 0-1
6)With measurable lesion
7)Adequate organ function
8)Written informed consent
Key exclusion criteria
1)Interstitial pneumonia or pulmonary fibrosis detectable on CT scan
2)History of severe drug allergy
3)EGFR mutation positive, ALK rearrangement positive, other driver oncogenes positive
4)History of serious disease condition
5)Symptomatic brain metastasis
6)History of active double cancer
7)History of pregnancy or lactation
8)History of active psychological disease
Target sample size
35
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Miyako Satouchi |
Organization
Hyogo Cancer Center
Division name
Department of Thoracic Oncology
Zip code
Address
13-70, Kitaoji-cho, Akashi, Hyogo 673-8558, Japan
TEL
078-929-1151
satouchi@hp.pref.hyogo.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoshihiro Hattori |
Organization
Hyogo Cancer Center
Division name
Department of Thoracic Oncology
Zip code
Address
13-70, Kitaoji-cho, Akashi, Hyogo 673-8558, Japan
TEL
078-929-1151
Homepage URL
hattori@hp.pref.hyogo.jp
Sponsor or person
Institute
Hyogo Cancer Center
Institute
Department
Personal name
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
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
| 2013 | Year | 09 | Month | 17 | 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
| 2013 | Year | 08 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 10 | 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
| 2013 | Year | 09 | Month | 16 | Day |
Last modified on
| 2018 | Year | 03 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013617
