UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000051645 |
|---|---|
| Receipt number | R000058799 |
| Scientific Title | Efficacy and safety of lenvatinib for patients with advanced or recurrent thymic carcinoma: A real-world retrospective study |
| Date of disclosure of the study information | 2023/07/19 |
| Last modified on | 2023/07/19 13:39:34 |
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Basic information
Public title
Efficacy and safety of lenvatinib for patients with advanced or recurrent thymic carcinoma: A real-world retrospective study
Acronym
Efficacy and safety of lenvatinib for patients with advanced or recurrent thymic carcinoma: A real-world retrospective study
Scientific Title
Efficacy and safety of lenvatinib for patients with advanced or recurrent thymic carcinoma: A real-world retrospective study
Scientific Title:Acronym
Efficacy and safety of lenvatinib for patients with advanced or recurrent thymic carcinoma: A real-world retrospective study
Region
| Japan |
Condition
Condition
Unresectable advanced or recurrent thymic carcinoma
Classification by specialty
| Pneumology | Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate the efficacy and safety of lenvatinib for patients with advanced or recurrent thymic carcinoma in the real world.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
The objective response rate in second or later-line treatment
Key secondary outcomes
The objective response rate in first-line treatment
Disease control rate
Progression-free survival
Time to treatment failure
Overall survival
Safety
Course of treatment, including dosage adjustment
Efficacy and safety of lenvatinib for ineligible patients in the REMORA study and elderly patients
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The subjects in this study are consecutive cases that meet all of the following criteria.
1. Patients pathologically diagnosed with thymic carcinoma
2. Patients aged 18 or over
3. Patients with any of the following a, b
a. Patients with unresectable thymic carcinoma diagnosed with stage III or IV by Masaoka-Koga classification
b. Patients with reccurent thymic carcinoma without indication for curative treatment
4. Patients started on lenvatinib from March 23, 2021 through October 31, 2022
Key exclusion criteria
Patients who have expressed their refusal to participate in this study through an information disclosure document
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Takuji |
| Middle name | |
| Last name | Suzuki |
Organization
Graduate School of Medicine, Chiba University
Division name
Department of respirology
Zip code
260-8670
Address
1-8-1, Inohana, Chuo-ku, Chiba-shi, Chiba, Japan
TEL
043-222-7171
suzutaku@chiba-u.jp
Public contact
Name of contact person
| 1st name | Kento |
| Middle name | |
| Last name | Takagi |
Organization
Graduate School of Medicine, Chiba University
Division name
Department of respirology
Zip code
260-8670
Address
1-8-1, Inohana, Chuo-ku, Chiba-shi, Chiba, Japan
TEL
043-222-7171
Homepage URL
kent.takagi@chiba-u.jp
Sponsor or person
Institute
Graduate School of Medicine, Chiba University
Institute
Department
Personal name
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
Ethics Committee for Observational Studies of Chiba University Hospital
Address
1-8-1, Inohana, Chuo-ku, Chiba-shi, Chiba, Japan
Tel
043-222-7171
hsp-kansaturinri@chiba-u.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
| 2023 | Year | 07 | Month | 19 | 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
Enrolling by invitation
Date of protocol fixation
| 2023 | Year | 04 | Month | 14 | Day |
Date of IRB
| 2023 | Year | 06 | Month | 05 | Day |
Anticipated trial start date
| 2023 | Year | 04 | Month | 14 | Day |
Last follow-up date
| 2023 | Year | 04 | Month | 14 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Study design: Multicenter retrospective observational study
Management information
Registered date
| 2023 | Year | 07 | Month | 19 | Day |
Last modified on
| 2023 | Year | 07 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000058799
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
