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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000023961
Receipt No. R000027583
Scientific Title Carboplatin and TS-1 combination chemotherapy in cancer of unknown primary site : a phase II multicenter trial
Date of disclosure of the study information 2016/09/06
Last modified on 2019/09/09

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Basic information
Public title Carboplatin and TS-1 combination chemotherapy in cancer of unknown primary site : a phase II multicenter trial
Acronym CBDCA and TS-1 in CUP Phase II study
Scientific Title Carboplatin and TS-1 combination chemotherapy in cancer of unknown primary site : a phase II multicenter trial
Scientific Title:Acronym CBDCA and TS-1 in CUP Phase II study
Region
Japan

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

Objectives
Narrative objectives1 Evaluate efficacy and safty of carboplatin and TS-1 combination therapy in cancer of unknown primary site
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes overall response rate
Key secondary outcomes adverse event, survival outcome(OS, PFS)

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 carboplatin AUC5, 60 min div day1
TS-1 80mg/m2, twice daily day1-14
until 6 cycles without progression
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 a) pathologically diagnosed cancer of unknown primary site
b) age over 20 years old
c) Performance status (ECOG) 0-2
d) evaluable lesion based on RECIST
e) met these criteria within 14 days before registration
WBC >=3,000/mm3 or Neutrophil count >=1,500/mm3
hemoglobin >=9.0g/dL
Platelet count >=10x104/mm3
T-bil <= 2.0mg/dl
AST or ALT <=100IU/L
serum Cre <=1.5mg/dL or CCr >=60ml/min(Cockcroft-Gault)
f) No prior chemotherapy history
g) Informed Consent from patient
Key exclusion criteria a) favorable subset of CUP
b) double cancer
c) uncontrollable effusion in pleural or abdominal
d) uncontrollable brain metastasis
e)sever coexisting illness
uncontrollable angina, AMI or congestive heart failure within 3 months,
uncontrollable diabetes melitus
active infection
interstitial pneumonitis in CXR
severe psychological problems
uncontrollable diarrhea
physician assessed the patient as ineligible
the patients have to continue flucitocin, phenytoin and warfarin
pregnant patients
Target sample size 35

Research contact person
Name of lead principal investigator
1st name Kan
Middle name
Last name Yonemori
Organization National Cancer Center Hospital
Division name Department of Breast and Medical Oncology
Zip code 104-0045
Address 5-1-1, Tsukiji, Chu-o-ku, Tokyo
TEL 03-3542-2511
Email kyonemor@ncc.go.jp

Public contact
Name of contact person
1st name Emi
Middle name
Last name Noguchi
Organization National Cancer Center Hospital
Division name Department of Breast and Medical Oncology
Zip code 104-0045
Address 5-1-1, Tsukiji, Chu-o-ku, Tokyo
TEL 03-3542-2511
Homepage URL
Email tshimoi@ncc.go.jp

Sponsor
Institute National Cancer Center Hospital
Institute
Department

Funding Source
Organization National Cancer Center
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor Tochigi Cancer Center
Name of secondary funder(s) Yokohama Rosai Hospital

IRB Contact (For public release)
Organization National Cancer Center Hospital
Address 5-1-1, Tsukiji, Chu-o-ku, Tokyo
Tel 03-3542-2511
Email irst@ml.res.ncc.go.jp

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
2016 Year 09 Month 06 Day

Related information
URL releasing protocol http:
Publication of results Unpublished

Result
URL related to results and publications http:
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Delay expected
Results Delay Reason in preparation
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 No longer recruiting
Date of protocol fixation
2008 Year 03 Month 10 Day
Date of IRB
2008 Year 06 Month 13 Day
Anticipated trial start date
2008 Year 06 Month 13 Day
Last follow-up date
2017 Year 03 Month 09 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 09 Month 06 Day
Last modified on
2019 Year 09 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027583

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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