UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019337 |
|---|---|
| Receipt number | R000022362 |
| Scientific Title | Low-dose chemotherapy with methotrexate and vinblastine for patients with desmoid tumors |
| Date of disclosure of the study information | 2015/10/14 |
| Last modified on | 2018/10/17 09:40:08 |
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Basic information
Public title
Low-dose chemotherapy with methotrexate and vinblastine for patients with desmoid tumors
Acronym
methotrexate and vinblastine for patients with desmoid tumors
Scientific Title
Low-dose chemotherapy with methotrexate and vinblastine for patients with desmoid tumors
Scientific Title:Acronym
methotrexate and vinblastine for patients with desmoid tumors
Region
| Japan |
Condition
Condition
desmoid
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To clarify the clinical outcome of methotrexate and vinblastine for desmoid tumors
Basic objectives2
Others
Basic objectives -Others
To evaluate relationship between clinical outcome and CTNNB1 mutation status
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Response rate with RECIST, and safety
Key secondary outcomes
relationship between clinical outcome and CTNNB1 mutation status
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
Methotrexate, Vinblastine
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
| 6 | years-old | <= |
Age-upper limit
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
not controlled desmoid tumor
Key exclusion criteria
not tolerated to chemotherapy
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshihiro Nishida |
Organization
Nagoya University Hospital
Division name
Orthopaedic Surgery
Zip code
Address
65-Tsurumai, Showa, Nagoya
TEL
052-741-2111
ynishida@med.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoshihiro Nishida |
Organization
Nagoya University Hospital
Division name
Orthopaedic Surgery
Zip code
Address
65-Tsurumai, Showa, Nagoya
TEL
052-741-2111
Homepage URL
ynishida@med.nagoya-u.ac.jp
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
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
名古屋大学医学部附属病院（愛知県）
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 10 | Month | 14 | Day |
Related information
URL releasing protocol
Publication of results
Partially 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
Completed
Date of protocol fixation
| 2002 | Year | 05 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 10 | Month | 15 | Day |
Last follow-up date
| 2017 | Year | 10 | Month | 14 | Day |
Date of closure to data entry
| 2017 | Year | 11 | Month | 14 | Day |
Date trial data considered complete
| 2017 | Year | 11 | Month | 20 | Day |
Date analysis concluded
| 2018 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2015 | Year | 10 | Month | 14 | Day |
Last modified on
| 2018 | Year | 10 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022362
