UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016728 |
|---|---|
| Receipt number | 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 17:00:28 |
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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
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
icchi@med.teikyo-u.ac.jp
Sponsor or person
Institute
Teikyo University School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018725
