UMIN-CTR Clinical Trial

Basic information
Public title	Phase II trial of treatment based on gene profiling diagnosis using next generation sequencing for carcinoma of unknown primary site
Acronym	Phase II trial of treatment strategy using NGS for carcinoma of unknown primary
Scientific Title	Phase II trial of treatment based on gene profiling diagnosis using next generation sequencing for carcinoma of unknown primary site
Scientific Title:Acronym	Phase II trial of treatment strategy using NGS for carcinoma of unknown primary
Region	Japan

Condition
Condition	Untreated Carcinoma of Unknown Primary Site
Classification by specialty	Medicine in general Hematology and clinical oncology
Classification by malignancy	Malignancy
Genomic information	YES

Objectives
Narrative objectives1	To evaluate the utility of the next generation sequencing assay in identifying the tissue of origin in patients with carcinoma of unknown primary site.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Phase II

Assessment
Primary outcomes	One year overall survival rate
Key secondary outcomes	Overall survival, Progression free survival, response rate, safety, exploratory anarysis association between results of gene profiling and efficacy, Frequency of gene mutation/amplification

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 Other
Interventions/Control_1	Treatment strategy using next generation sequencing
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 must have biopsy-proven metastatic carcinoma (2)No previous treatment with any systemic therapy. (3)Patients must have biopsy material available to provide an adequate specimen for the gene profiling assay. (4)Age, over 20 years old. (5)An ECOG performance status 0, 1, or 2. (6)Laboratory values as follows: WBC 4000/micro L, Platelets 100,000/micro L, Serum AST/ALT <100 IU/L Serum bilirubin <1.5 mg/dl Serum creatinine < 1.5 mg/dL.
Key exclusion criteria	(1)Patients with the specific sub groups are not eligible: (2)Patients with uncontrolled brain metastases and all patients with meningeal metastases. (3)Women who are pregnant or lactating. drug within 28 days of starting treatment
Target sample size	110

Research contact person
Name of lead principal investigator	1st name Middle name Last name Kazuhiko Nakagawa
Organization	Kinki University, Faculty of Medicine
Division name	Department of Medical Oncology
Zip code
Address	377-2, Ohnohigashi, Osaka-sayama city, Osaka
TEL	072-366-0221
Email	nakagawa@med.kindai.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Hidetoshi Hayashi
Organization	Kishiwada City Hospital
Division name	Department of Medical Oncology
Zip code
Address	1001 Gakuharacho, Kishiwada, Osaka
TEL	072-445-1000
Homepage URL
Email	hidet31@gmail.com

Sponsor
Institute	Ministry of Health, Labour and Welfare scientific research Nakagawa squad
Institute
Department

Funding Source
Organization	Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization
Nationality of Funding Organization	Japan

Other related organizations
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IRB Contact (For public release)
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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	近畿大学医学部附属病院 市立岸和田市民病院 関西医科大学付属枚方病院 和歌山県立医科大学付属病院 千葉大学医学部附属病院　 静岡県立静岡がんセンター 虎の門病院 東北大学　 栃木県立がんセンター 大阪市立総合医療センター　 兵庫県立がんセンター 神戸大学医学部付属病院 埼玉医科大学国際医療センター 国立がん研究センター東病院　 岐阜市民病院　 がん研究会有明病院

Other administrative information
Date of disclosure of the study information	2015 Year 03 Month 13 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	Completed
Date of protocol fixation	2015 Year 02 Month 24 Day
Date of IRB	2015 Year 03 Month 07 Day
Anticipated trial start date	2015 Year 03 Month 10 Day
Last follow-up date	2019 Year 01 Month 31 Day
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 13 Day
Last modified on	2022 Year 03 Month 18 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019494

Research Plan
Registered date	File name

Research case data specifications
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Research case data
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