UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000482 |
|---|---|
| Receipt number | R000000583 |
| Scientific Title | A phase II study for anaplastic thyroid cancer |
| Date of disclosure of the study information | 2006/09/01 |
| Last modified on | 2006/09/01 10:45:36 |
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Basic information
Public title
A phase II study for anaplastic thyroid cancer
Acronym
A phase II study for anaplastic thyroid cancer
Scientific Title
A phase II study for anaplastic thyroid cancer
Scientific Title:Acronym
A phase II study for anaplastic thyroid cancer
Region
| Japan |
Condition
Condition
anaplastic thyroid cancer
Classification by specialty
| Endocrinology and Metabolism | Endocrine surgery | Oto-rhino-laryngology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy of docetaxel for anaplastic thyroid cancer
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
Response rate
Key secondary outcomes
The median survival and side effects
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
docetaxelat 60 mg/m2
The interval is 3 weeks
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
The eligibility criteria are pathologically proven anaplastic thyroid cancer;age, equal or more than 20 years old; at least one measureable lesion; adequate bone marrow, liver, and renal function; performance status of 0 to 2; no previous chemotherapy; written informed consent is required
Key exclusion criteria
heavy thoracic, abdominal, or pericardial dropsy;
heavy complications such as myocarial infarction, heat failure, cerebral infarctio within 6 months; uncontrolled diabetes; uncontrolled hypertension;symptomatic brain metastases;
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yuichi Ando |
Organization
Nagoya university hospital
Division name
Clinical oncology and chemotherapy
Zip code
Address
65 Tsurumai, Showa Nagoya
TEL
052-744-1903
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kenji Kawada |
Organization
Nagoya university hospital
Division name
Clinical oncology and chemotherapy
Zip code
Address
65 Tsurumai, Showa Nagoya
TEL
052-744-1903
Homepage URL
Sponsor or person
Institute
Nagoya university hospital
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
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
| 2006 | Year | 09 | 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
| 2006 | Year | 08 | Month | 21 | Day |
Date of IRB
Anticipated trial start date
| 2006 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 08 | 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
| 2006 | Year | 09 | Month | 01 | Day |
Last modified on
| 2006 | Year | 09 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000583
