UMIN-CTR Clinical Trial

Basic information
Public title	A phase II study of cisplatin with TS-1 for patients with cancer of primary unknown
Acronym	A phase II study of cisplatin with TS-1
Scientific Title	A phase II study of cisplatin with TS-1 for patients with cancer of primary unknown
Scientific Title:Acronym	A phase II study of cisplatin with TS-1
Region	Japan

Condition
Condition	cancer of primary unknown
Classification by specialty	Hematology and clinical oncology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To investigate the effect of cisplatin with TS-1 for patients for patients with cancer of primary unknown
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Phase II

Assessment
Primary outcomes	Response Rate
Key secondary outcomes	Safety Profile

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
Interventions/Control_1	Chemotherapy
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	99 years-old >=
Gender	Male and Female
Key inclusion criteria	The eligibility criteria are as follows;(1) histologic or cytologic confirmation of metastatic cancer with unknown primary site (2) not subject to radiation or surgery(3) measurable or evaluable lesions; (4) no previous treatments (5) Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2 (6)age more than 20 (7) adequate organ function (8) written informed consent
Key exclusion criteria	The exclusion criteria are as follows: 1.female adenocarcinoma with axillary lymph nodes swelling only, or pelvic cavity endolymph nodes only 2.squamous carcinoma with cervical lymph nodes swelling only, or inguen lymph nodes only 3.patients with germ cell tumor or have characteristic of neuroendocrine tumor 4.patients with high level of PSA in serum or tumor (1) severe infection or other severe complications (such as gastrointestinal bleeding, heart disease) (2) symptomatic brain metastasis (3) patients who carried out bone marrow transplantation (4) patients who carried out peripheral blood stem cell transplantation (5) drug allergy (6) pregnancy or lactating (7) male patients who hope for pregnancy (8) uncontrollable diabetes mellitus
Target sample size	45

Research contact person
Name of lead principal investigator	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
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	Department of Medical Oncology, Kinki University School of Medicine
Institute
Department

Funding Source
Organization	Department of Medical Oncology, Kinki University School of Medicine
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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	2005 Year 10 Month 31 Day

Related information
URL releasing protocol
Publication of results	Published

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	Main results already published
Date of protocol fixation	2005 Year 10 Month 01 Day
Date of IRB
Anticipated trial start date	2005 Year 10 Month 01 Day
Last follow-up date	2010 Year 09 Month 01 Day
Date of closure to data entry	2011 Year 12 Month 01 Day
Date trial data considered complete	2011 Year 12 Month 01 Day
Date analysis concluded	2011 Year 12 Month 01 Day

Other
Other related information

Management information
Registered date	2005 Year 10 Month 31 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=R000000342

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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