UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023961 |
|---|---|
| Receipt number | 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 | 2022/09/11 09:16:50 |
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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
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
tshimoi@ncc.go.jp
Sponsor or person
Institute
National Cancer Center Hospital
Institute
Department
Personal name
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
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
Published
Result
URL related to results and publications
http:
Number of participants that the trial has enrolled
35
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
Main results already published
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
| 2022 | Year | 09 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027583
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
