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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000001919
Receipt No. R000002034
Scientific Title Randomized phase II study comparing chemotherapy led by using the classification of primary tumor origin with empirical chemotherapy for patients with unknown primary cancer .
Date of disclosure of the study information 2009/04/30
Last modified on 2018/03/04

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Basic information
Public title Randomized phase II study comparing chemotherapy led by using the classification of primary tumor origin with empirical chemotherapy for patients with unknown primary cancer .
Acronym Randomized phase II study for patients with unknown primary cancer.
Scientific Title Randomized phase II study comparing chemotherapy led by using the classification of primary tumor origin with empirical chemotherapy for patients with unknown primary cancer .
Scientific Title:Acronym Randomized phase II study for patients with unknown primary cancer.
Region
Japan

Condition
Condition cancer of unknown primary
Classification by specialty
Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 To evaluate whether a treatment strategy led by using the classification of the primary tumor origin by DNA microarrays is important.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes one-year survival rate
Key secondary outcomes overall survival, progression free survival, response rate

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation YES
Institution consideration Institution is not considered as adjustment factor.
Blocking YES
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 chemotherapy regimen led by using the classification of the origin of the primary tumor by microarray
Interventions/Control_2 empirical chemotherapy consisted of carboplatin and paclitaxel
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)histologically or cytologically proven epithelial cancer that is defined by the presence of metastatic disease for which a primary site is undetectable at the time of registration
(2)no previous chemotherapy
(3)tumor tissue can be obtained before treatment
(4)age, more than 20 years old
(5)PS 0-2
(6)appropriate organ function
(7)written informed consent
Key exclusion criteria (1)cases with the adaptation of radical operation and the radical irradiation
(2)Patient subgroups known to have favorable features are excluded. These subgroups include as follows:
(a)women with adenocarcinoma involving only axillary lymph nodes
(b)women with adenocarcinoma involving the peritoneal cavity
(c)patients with squamous cell carcinoma involving only cervical lymph nodes
(d)patients with squamous cell carcinoma involving only inguinal lymph nodes
(e)patients with poorly differentiated carcinoma consistent with a germ cell tumor or neuroendcrine carcinomas
(f)men with osteosclerosis-related bone metastases and elevated PSA in their plasma or tumor
(3)active infection or other severe complications (such as gastrointestinal bleeding, heart disease)
(4)symptomatic brain tumor
(5)interstitial pneumonitis or pulmonary fibrosis
(6)patients who underwent bone marrow transplantation
(7)patients who underwent peripheral blood stem cell transplantation
(8)severe drug allergy
(9)alcohol intolerance
(10) HBsAg(+)
(11)pregnant or lactating women
(12)men with the pregnant intention
(13)uncontrollable diabetis mellitus
Target sample size 120

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kazuhiko Nakagawa
Organization Kinki University School of Medicine
Division name Department of medical Oncology
Zip code
Address 377-2, Ohno-Higashi, Osakasayama, Osaka
TEL 072-366-0221
Email kuratat@hirakata.kmu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Takayasu Kurata
Organization Kinki University School of Medicine
Division name Department of medical Oncology
Zip code
Address 377-2, Ohno-Higashi, Osakasayama, Osaka
TEL 072-366-0221
Homepage URL
Email t-kurata@med.kindai.ac.jp

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 Japanese Governmental office
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

Other administrative information
Date of disclosure of the study information
2009 Year 04 Month 30 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 No longer recruiting
Date of protocol fixation
2008 Year 07 Month 01 Day
Date of IRB
Anticipated trial start date
2008 Year 09 Month 01 Day
Last follow-up date
2017 Year 02 Month 01 Day
Date of closure to data entry
2018 Year 02 Month 01 Day
Date trial data considered complete
2018 Year 03 Month 01 Day
Date analysis concluded
2018 Year 04 Month 01 Day

Other
Other related information

Management information
Registered date
2009 Year 04 Month 30 Day
Last modified on
2018 Year 03 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002034

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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