UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | C000000271 |
|---|---|
| Receipt number | R000000342 |
| Scientific Title | A phase II study of cisplatin with TS-1 for patients with cancer of primary unknown |
| Date of disclosure of the study information | 2005/10/31 |
| Last modified on | 2018/03/04 21:56:39 |
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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
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
t-kurata@med.kindai.ac.jp
Sponsor or person
Institute
Department of Medical Oncology, Kinki University School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000342
| Research Plan | |
|---|---|
| Registered date | File name |
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| Registered date | File name |
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