UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034206 |
|---|---|
| Receipt number | R000038195 |
| Scientific Title | Clinical outcome of trabectedin in Japanese patients with soft tissue sarcoma; JMOG multicenter study |
| Date of disclosure of the study information | 2018/09/21 |
| Last modified on | 2021/03/23 13:45:37 |
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Basic information
Public title
Clinical outcome of trabectedin in Japanese patients with soft tissue sarcoma; JMOG multicenter study
Acronym
Clinical outcome of trabectedin in Japanese patients with soft tissue sarcoma; JMOG multicenter study
Scientific Title
Clinical outcome of trabectedin in Japanese patients with soft tissue sarcoma; JMOG multicenter study
Scientific Title:Acronym
Clinical outcome of trabectedin in Japanese patients with soft tissue sarcoma; JMOG multicenter study
Region
| Japan |
Condition
Condition
Malignant soft tissue tumor
Classification by specialty
| Orthopedics |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and safety of trabectedin in patients with soft tissue sarcoma
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Progressive-free survival
Key secondary outcomes
Survival
Side effect (CTCAE)
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. The aim to use trabectedin is for local recurrent or metastatic tumor
2. The existence of tumors which can be evaluated by radiological examination when treatment using trabectedin is started.
Key exclusion criteria
Patients who are not treated in the registered institutions of Japanese Musculoskeletal Oncology Group will be excluded from this study.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Sakae |
| Middle name | |
| Last name | Tanaka |
Organization
The University of Tokyo Hospital
Division name
Orthopaedic department
Zip code
113-8655
Address
7-3-1, Hongo, Bunkyo-ku, Tokyo
TEL
03-3815-5411
tanakas-ort@h.u-tokyo.ac.jp
Public contact
Name of contact person
| 1st name | Hiroshi |
| Middle name | |
| Last name | Kobayashi |
Organization
The University of Tokyo Hospital
Division name
Orthopaedic department
Zip code
113-8655
Address
7-3-1, Hongo, Bunkyo-ku, Tokyo
TEL
03-3815-5411
Homepage URL
hkobayashi-tky@umin.ac.jp
Sponsor or person
Institute
Japanese Musculoskeletal Oncology Group
Institute
Department
Personal name
Funding Source
Organization
Japanese Musculoskeletal Oncology Group
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The University of Tokyo Hospital
Address
7-3-1, Hongo, Bunkyo-ku, Tokyo
Tel
03-3815-5411
hkobayashi-tky@umin.ac.jp
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 | 09 | Month | 21 | Day |
Related information
URL releasing protocol
https://pubmed.ncbi.nlm.nih.gov/31825533/
Publication of results
Published
Result
URL related to results and publications
https://pubmed.ncbi.nlm.nih.gov/31825533/
Number of participants that the trial has enrolled
140
Results
Initial trabectedin at 1.2 mg/m2 has clinically meaningful benefits for patients with L-sarcoma and certain histological subtypes of TRS.
Results date posted
| 2021 | Year | 03 | Month | 23 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
patients with unresectable and relapsed STS
Participant flow
This study retrospectively investigated its efficacy and safety through postmarketing surveillance of trabectedin in patients with unresectable and relapsed STS.
Adverse events
no
Outcome measures
PFS, OS, ORR
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2017 | Year | 09 | Month | 22 | Day |
Date of IRB
| 2017 | Year | 09 | Month | 21 | Day |
Anticipated trial start date
| 2017 | Year | 09 | Month | 22 | Day |
Last follow-up date
| 2018 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
observational study
Management information
Registered date
| 2018 | Year | 09 | Month | 20 | Day |
Last modified on
| 2021 | Year | 03 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038195
