UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030998 |
|---|---|
| Receipt number | R000035383 |
| Scientific Title | Combination chemotherapy with methotrexate and vinblastine for surgically unresectable, aggressive desmoid tumor |
| Date of disclosure of the study information | 2018/01/25 |
| Last modified on | 2019/05/10 17:19:38 |
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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
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
seikei@med.kanazawa-u.ac.jp
Public contact
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
khayashi830@gmail.com
Sponsor or person
Institute
Kanazawa University Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035383
