UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001358 |
|---|---|
| Receipt number | R000001655 |
| Scientific Title | A Phase II Study of carboplatin plus paclitaxel for advanced thymic cancer |
| Date of disclosure of the study information | 2008/09/08 |
| Last modified on | 2015/08/31 16:11:18 |
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Basic information
Public title
A Phase II Study of carboplatin plus paclitaxel for advanced thymic cancer
Acronym
Carboplatin plus paclitaxel for advanced thymic cancer
Scientific Title
A Phase II Study of carboplatin plus paclitaxel for advanced thymic cancer
Scientific Title:Acronym
Carboplatin plus paclitaxel for advanced thymic cancer
Region
| Japan |
Condition
Condition
Thymic cancer
Classification by specialty
| Pneumology | Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To assess the efficacy and safety of carboplatin plus paclitaxel in patients with advanved thymic cancer.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
Objective response rate (RECIST criteria)
Key secondary outcomes
Overall survival, Progression survival, Safety
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Carboplatin+Paclitaxel
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
1)Histologically confirmed thymic carcinoma.
2)Clinically confirmed Masaoka stage III, IVa or IVb not amenable to potentially curative therapy by surgery or radiotherapy.
3)Patients without prior chemotherapy.
4)Recurrence after surgery or radiotherapy but recurrent sites have never been irradiated.
5)Measurable lesion
6)Adult patients (20 years of age or more than 20)
7)Performance status 0-1
8)Adequate organ function
9)Written informed consent
Key exclusion criteria
1)Presence of pleural or pericardial effusion that cannot be controlled by a procedure.
2)Presence of brain tumor with clinical symptoms.
3)Superior vena cava syndrome.
4)Interstitial pneumonitis.
5)Presence of other active malignancy.
6)Acute intercurrent infection or complications
7)History of serious allergy to medical drugs.
8)Uncontrolled psychiatric disease.
9)pregnancy or lactating patients
10)Myasthenia gravis
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takashi Seto |
Organization
National Kyushu Cancer Center
Division name
Department of Thoracic Oncology
Zip code
Address
Notame 3-1-1, Minami-ku, Fukuoka, 811-1395, Japan
TEL
092-541-3231
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shinichiro Nakamura |
Organization
West Japan Oncology Group
Division name
WJOG datacenter
Zip code
Address
Namba Plaza Bldg.3F 1-5-7,Motomachi Naniwa-ku,Osaka556-0016 JAPAN
TEL
06-6633-7400
Homepage URL
datacenter@wjog.jp
Sponsor or person
Institute
West Japan Oncology Group
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
Other administrative information
Date of disclosure of the study information
| 2008 | Year | 09 | Month | 08 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
http://www.ncbi.nlm.nih.gov/pubmed?term=25403584
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
Completed
Date of protocol fixation
| 2008 | Year | 03 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2008 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2015 | Year | 05 | 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 | 09 | Month | 08 | Day |
Last modified on
| 2015 | Year | 08 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001655
