UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001236 |
|---|---|
| Receipt number | R000001508 |
| Scientific Title | Phase II study in combination with Carboplatin and TS-1 for Cancer of unknown primary |
| Date of disclosure of the study information | 2008/08/01 |
| Last modified on | 2012/01/10 15:45:07 |
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Basic information
Public title
Phase II study in combination with Carboplatin and TS-1 for Cancer of unknown primary
Acronym
CBDCA/TS-1 for CUP
Scientific Title
Phase II study in combination with Carboplatin and TS-1 for Cancer of unknown primary
Scientific Title:Acronym
CBDCA/TS-1 for CUP
Region
| Japan |
Condition
Condition
Cancer of unknown primary
Classification by specialty
| Medicine in general |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate efficacy in combination with Carboplatin and TS-1 for cancer of unknown primary
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
Response rate (RECIST criteria)
Key secondary outcomes
Adverse events (NCI-CTC/AE version 3)
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
Carboplatin AUC5 (day1)
TS-1 (P.O.) 40 mg/m-2 BID (day1 - 14)
max 6 cycles or until PD
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
a) Cancer of unknown primary (histologically proven carcinoma, primary site was not detected by systemic survey)
b) Age >= 20 yrs
c) Performance status (ECOG) 0-2
d) Mesurable lesion by the RECIST criteria
e) Adequate organ functions
f) no prior chemotherapy for CUP
g) written informed consent
Key exclusion criteria
a) Specific subgroups of CUP
(female(adenocarcinoma, Ax LN metastases), female (adenocarcinoma, peritonitis carcinomatosa), squamous cell carcinoma of cervical LN metastases, etc.)
b) history of any malignancies
c) massive effusion (thorax or abdominal cavity)
d) symptomatic brain metastases
e) uncontrolled cormobity (DM, hypertension, infection)
f) internal use of phenytoine, flucytosyne, or warfarin
Target sample size
35
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masashi Ando |
Organization
National Cancer Center Hospital, Tokyo
Division name
Dept of Breast and Oncology
Zip code
Address
Tskiji 1-1, 5 Cho-me, Chuo-ku, Tokyo, Japan
TEL
03-3542-2511
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masashi Ando |
Organization
National Cancer Center Hospital, Tokyo
Division name
Dept of Breast and Oncology
Zip code
Address
TEL
Homepage URL
Sponsor or person
Institute
National Cancer Center Hospital, Tokyo
Institute
Department
Personal name
Funding Source
Organization
None
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
国立がん研究センター中央病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2008 | Year | 08 | Month | 01 | 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
Date of protocol fixation
| 2008 | Year | 05 | Month | 16 | Day |
Date of IRB
Anticipated trial start date
| 2008 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 06 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2008 | Year | 07 | Month | 09 | Day |
Last modified on
| 2012 | Year | 01 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001508
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
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