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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000013219
Receipt No. R000015425
Scientific Title Phase I/II trial of nab-PTX/CDGP for chemo-naive patients with advanced squamous cell lung cancer (KRSG-1302)
Date of disclosure of the study information 2014/02/21
Last modified on 2014/02/21

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Basic information
Public title Phase I/II trial of nab-PTX/CDGP for chemo-naive patients with advanced squamous cell lung cancer (KRSG-1302)
Acronym Phase I/II trial of nab-PTX/CDGP for patients with advanced squamous cell lung cancer (KRSG-1302)
Scientific Title Phase I/II trial of nab-PTX/CDGP for chemo-naive patients with advanced squamous cell lung cancer (KRSG-1302)
Scientific Title:Acronym Phase I/II trial of nab-PTX/CDGP for patients with advanced squamous cell lung cancer (KRSG-1302)
Region
Japan

Condition
Condition Squamous cell lung cancer
Classification by specialty
Pneumology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study is to determine the recommended dose of nab-paclitaxel plus nedaplatin in chemo-naive patients with advanced squamous cell lung cancer and to assess the efficacy and safety with recommended dose.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Phase I,II

Assessment
Primary outcomes Phase I: To determine the maximum tolerated dose and to estimate the recommended dose
Phase II: response rate
Key secondary outcomes Phase I: Safety, Response rate
Phase II: Progression-free survival, Overall survival, 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 Phase I
LEVEL2
nab-PTX: 100 mg/m2 (day1,8,15; q3w)
CDGP: 100 mg/m2 (day1; q3w)
LEVEL1
nab-PTX: 100 mg/m2 (day1,8, q3w)
CDGP: 100 mg/m2 (day1; q3w)
LEVEL0
nab-PTX: 100 mg/m2 (day1,8, q3w)
CDGP: 80 mg/m2 (day1; q3w)
LEVEL-1
nab-PTX: 80 mg/m2 (day1,8, q3w)
CDGP 80: mg/m2 (day1; q3w)
Phase II
nab-PTX: RD, Recommended schedule
CDGP: RD (day1; q3w)
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 1) Definitively diagnosed with squamous cell lung cancer by the specimens histologically or cytologically.
2) Stage III/IV without any indications for radiotherapy
3) No prior chemotherapy
Adjuvant chemotherapy of UFT finished before 4 weeks from enrollment or more is permitted.
4) With a measurable lesion
5) Age of 20 to 75 years
6) Without active cancer other than NSCLC
7) ECOG performance status 0 or 1
8) With adequate organ function
Key exclusion criteria 1) Symptomatic brain metastasis
2) Pregnant females, possibly pregnant females, females wishing to become pregnant and nursing mothers. Males that are currently attempting to produce a pregnancy
3) With active double cancer or multicentric cancer
4) .>= G2 peripheral neuropathy (CTCAE)
5) Treated with radiotherapy within the past four weeks.
6) With clinically important complications.
7) Interstitial pneumonia or pulmonary fibrosis becomes the clinical problem
8) With pleural effusion or pericardial effusion accumulates which need drainage
9) With the history of hypersensivity for component of human plasma with albumin, nab-PTX, or CDGP
10) Main organs had a serious medical risk factor, and the physicians judged treatment not to be safe.
11) Physician concludes that the patient's participation in this trial is inappropriate
Target sample size 23

Research contact person
Name of lead principal investigator
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
TEL 028-658-5151
Email takasai@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
TEL 028-658-5151
Homepage URL
Email takasai@tcc.pref.tochigi.lg.jp

Sponsor
Institute Kanto respiratory disease study group
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
2014 Year 02 Month 21 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 Open public recruiting
Date of protocol fixation
2013 Year 07 Month 29 Day
Date of IRB
Anticipated trial start date
2013 Year 07 Month 29 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 02 Month 21 Day
Last modified on
2014 Year 02 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015425

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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