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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000016728
Receipt No. R000018725
Scientific Title Efficacy and safety of nab-paclitaxel plus carboplatin in patients with Carcinoma of unknown primary site
Date of disclosure of the study information 2015/03/06
Last modified on 2015/03/06

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Basic information
Public title Efficacy and safety of nab-paclitaxel plus carboplatin in patients with Carcinoma of unknown primary site
Acronym Efficacy and safety of CBDCA plus nab-PTX in patients with CUP
Scientific Title Efficacy and safety of nab-paclitaxel plus carboplatin in patients with Carcinoma of unknown primary site
Scientific Title:Acronym Efficacy and safety of CBDCA plus nab-PTX in patients with CUP
Region
Japan

Condition
Condition Carinoma of unknown primary site(CUP)
Classification by specialty
Medicine in general Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Patients with cancer of unknown primary site(CUP) are treated by a combination chemotherapy of nab-paclitaxel and carboplatin(CBDCA) as a first-line chemotherapy. We analyze the efficacy(1-year survival rate,RR, PFS, OS) and safety.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes 1-year survival rate
Key secondary outcomes progression free survival, overall survival,response rate,tumor control rate,adverse event,QOL

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 is administered as a 30-minute infusion at a dose of 100mg/m2 on days 1,8,and 15 followed by carboplatin at an AUC of5 mg.min/ml(per Calvert formula) given on day1, every 21 days. Responding patients and patients with stable disease have a four-cycle minimum.
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)Patients with histologically comfirmed metastatic malignant lesion, with no identifiable primary site by physical examination, imaging, and laboratory examination.
2)No prior chemotherapy for CUP
3)Patients should be 20 years or older at informed consent.
4)ECOG PS scale: 0-2
5)Patient with enough feasibility for planned chemotherapy(hematological, liver, renal, cardiopulmonary function).
6)Written informed consent.
Key exclusion criteria 1)Indication for radical operation and radiotherapy.
2)Patients unable to take nab-paclitaxel and CBDCA because of significant cardiovascular abnormalities, renal dysfunctions, hepatic insufficiency, uncontrolled diabetes, uncontrolled hypertension, bleeding tendency, active interstitial pneumonia,etc.
3)Known active brain metastasis.
4)Acute or subacute idiopathic interstitial pneumonia
5)Patient received a bone-marrow transplantation
6)Patient received a peripheral stem cell transplantation
7)Known hypersensitivity to any drugs
8)Seropositivity for HBsAg
9)Pregnancy or breast feeding.
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Nobuhiko Seki
Organization Teikyo University School of Medicine
Division name Division of Medical Oncology,Department of Internal Mediine
Zip code
Address 2-11-1 Kaga,Itabashi-ku,Tokyo,JAPAN
TEL 03-3964-1211
Email nseki@med.teikyo-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yasuko Ichikawa
Organization Teikyo University School of Medicine
Division name Division of Medical Oncology,Department of Internal Mediine
Zip code
Address 2-11-1 Kaga,Itabashi-ku,Tokyo,JAPAN
TEL 03-3964-1211
Homepage URL
Email icchi@med.teikyo-u.ac.jp

Sponsor
Institute Teikyo University School of Medicine
Institute
Department

Funding Source
Organization none
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization JAPAN

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
2015 Year 03 Month 06 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
2014 Year 10 Month 15 Day
Date of IRB
Anticipated trial start date
2015 Year 01 Month 13 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
2015 Year 03 Month 06 Day
Last modified on
2015 Year 03 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018725

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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