UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000016794
Receipt number R000019494
Scientific Title Phase II trial of treatment based on gene profiling diagnosis using next generation sequencing for carcinoma of unknown primary site
Date of disclosure of the study information 2015/03/13
Last modified on 2022/03/18 12:46:27

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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 or person

Institute

Ministry of Health, Labour and Welfare scientific research Nakagawa squad

Institute

Department

Personal name



Funding Source

Organization

Ministry of Health, Labour and Welfare

Organization

Division

Category of Funding Organization

Nationality of Funding Organization

Japan


Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



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

Value
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
Registered date File name

Research case data
Registered date File name