UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001919 |
|---|---|
| Receipt number | 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 21:56:05 |
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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
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
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
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002034
