UMIN-CTR Clinical Trial

Basic information
Public title	Combination chemotherapy with methotrexate and vinblastine for surgically unresectable, aggressive desmoid tumor
Acronym	Chemotherapy for desmoid
Scientific Title	Combination chemotherapy with methotrexate and vinblastine for surgically unresectable, aggressive desmoid tumor
Scientific Title:Acronym	Chemotherapy for desmoid
Region	Japan

Condition
Condition	desmoid tumor
Classification by specialty	Orthopedics
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To check the clinical benefit and safety of chemotherapy using methotrexate and vinblastine in patients with progressive desmoid tumor.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Safety
Key secondary outcomes	PFS

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	A doseof 30 mg/m 2of methotrexate and 5 mg/m of vinblastine was administered weekly by intravenous infusion
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	16 years-old <=
Age-upper limit	85 years-old >
Gender	Male and Female
Key inclusion criteria	pathological diagnosed with desmoid Progressive disease with previous treatment 16 years old or more and 85 or less Neu over 1,000/mm3 Plt over 75,000/mm3 Hb over 8.0g/dl AST(GOT)ALT(GPT)150U/L or less T-bli : 3 or less CCr: 30 or more ECOG Performance Status 0 to 2 Informed Consent is obtained
Key exclusion criteria	contraindication for methotrexate or vinblastine, severe heart disease, renal dyfunction, respiratory failure, caogulation disorder pregnant Other medical, social, or psychological conditions that in the opinion of an investigator precludes the patient from appropriate consent
Target sample size	6

Research contact person
Last name of lead principal investigator	1st name Middle name Last name Hiroyuki Tsuchiya
Organization	Kanazawa University Hospital
Division name	Orthopaedic department
Zip code
Address	Takaramachi13-1, Kanazawa
TEL	0762652374
Email	seikei@med.kanazawa-u.ac.jp

Public contact
1st name of contact person	1st name Middle name Last name Katsuhiro Hayashi
Organization	Kanazawa University Hospital
Division name	Orthopaedic department
Zip code
Address	Takaramachi13-1, Kanazawa
TEL	0762652374
Homepage URL
Email	khayashi830@gmail.com

Sponsor
Institute	Kanazawa University Hospital
Institute
Department

Funding Source
Organization	Kanazawa University Hospital
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

Other administrative information
Date of disclosure of the study information	2018 Year 01 Month 25 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	Terminated
Date of protocol fixation	2018 Year 01 Month 25 Day
Date of IRB	2018 Year 01 Month 25 Day
Anticipated trial start date	2018 Year 02 Month 01 Day
Last follow-up date	2019 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Transfered to another database

Management information
Registered date	2018 Year 01 Month 25 Day
Last modified on	2019 Year 05 Month 10 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035383