UMIN-CTR Clinical Trial

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	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000027583