UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Low-dose chemotherapy with methotrexate and vinblastine for patients with desmoid tumors
Title of the study (Brief title)	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	Yoshihiro Nishida
Organization	Nagoya University Hospital
Division name	Orthopaedic Surgery
Address	65-Tsurumai, Showa, Nagoya
TEL	052-741-2111
Email	ynishida@med.nagoya-u.ac.jp

Public contact
Name of contact person	Yoshihiro Nishida
Organization	Nagoya University Hospital
Division name	Orthopaedic Surgery
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2002 Year 05 Month 20 Day
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

Related information
URL releasing protocol
Publication of results	Partially published
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000022362