UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Randomized phase II study comparing chemotherapy led by using the classification of primary tumor origin with empirical chemotherapy for patients with unknown primary cancer .
Title of the study (Brief title)	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	Kazuhiko Nakagawa
Organization	Kinki University School of Medicine
Division name	Department of medical Oncology
Address	377-2, Ohno-Higashi, Osakasayama, Osaka
TEL	072-366-0221
Email	kuratat@hirakata.kmu.ac.jp

Public contact
Name of contact person	Takayasu Kurata
Organization	Kinki University School of Medicine
Division name	Department of medical Oncology
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)

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

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2008 Year 07 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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