UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000019337
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Email 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
Email ynishida@med.nagoya-u.ac.jp

Sponsor
Institute Nagoya University Hospital
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022362

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.