UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060733 |
|---|---|
| Receipt number | R000069478 |
| Scientific Title | A Study on the Significance of Combining Kampo Medicine with the Molecular Targeted Drug Lenvatinib for Unresectable Thyroid Cancer and Related Drug Interactions |
| Date of disclosure of the study information | 2026/02/28 |
| Last modified on | 2026/02/22 20:44:43 |
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Basic information
Public title
A Study on the Significance of Combining Kampo Medicine with the Molecular Targeted Drug Lenvatinib for Unresectable Thyroid Cancer and Related Drug Interactions
Acronym
A Study on the Significance of Combining Kampo Medicine with the Molecular Targeted Drug Lenvatinib for Unresectable Thyroid Cancer and Related Drug Interactions
Scientific Title
A Study on the Significance of Combining Kampo Medicine with the Molecular Targeted Drug Lenvatinib for Unresectable Thyroid Cancer and Related Drug Interactions
Scientific Title:Acronym
A Study on the Significance of Combining Kampo Medicine with the Molecular Targeted Drug Lenvatinib for Unresectable Thyroid Cancer and Related Drug Interactions
Region
| Japan |
Condition
Condition
Thyroid cancer
Classification by specialty
| Endocrine surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate the significance of combining Kampo medicine with supportive therapy during lenvatinib treatment for unresectable advanced thyroid cancer
Basic objectives2
Others
Basic objectives -Others
To investigate the effect of concomitant use of Kampo medicine on the blood concentration of Lenvima during supportive therapy with lenvatinib for unresectable advanced thyroid cancer.
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Overall survival as of April 30, 2020
Key secondary outcomes
Progression-free survival rate, response rate, dose intensity of lenvatinib and blood concentration of lenvatinib as of April 30, 2020
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
YES
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Combined use of Kampo medicine
Interventions/Control_2
No concomitant use of Kampo medicine
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
| 20 | years-old | <= |
Age-upper limit
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients with unresectable advanced thyroid cancer who initiated lenvatinib therapy at Ito Hospital between May 1, 2015, and December 31, 2019
Key exclusion criteria
Consent for this study could not be obtained
Target sample size
74
Research contact person
Name of lead principal investigator
| 1st name | Akifumi |
| Middle name | |
| Last name | Suzuki |
Organization
Ito Hospital
Division name
Department of surgery
Zip code
150-8308
Address
4-3-6 Jingumae, Shibuya-ku, Tokyo, Japan
TEL
03-3402-7411
af-suzuki@ito-hospital.jp
Public contact
Name of contact person
| 1st name | Akifumi |
| Middle name | |
| Last name | Suzuki |
Organization
Ito Hospital
Division name
Department of surgery
Zip code
150-8308
Address
4-3-6 Jingumae, Shibuya-ku, Tokyo, Japan
TEL
03-3402-7411
Homepage URL
af-suzuki@ito-hospital.jp
Sponsor or person
Institute
Ito Hospital
Institute
Department
Personal name
Funding Source
Organization
Ito Hospital
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Akita University
Name of secondary funder(s)
Tsumura Co., Ltd.
IRB Contact (For public release)
Organization
Ito Hospital
Address
4-3-6 Jingumae, Shibuya-ku, Tokyo, Japan
Tel
03-3402-7411
af-suzuki@ito-hospital.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
2430
Org. issuing International ID_1
Akita University
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
伊藤病院
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 02 | Month | 28 | 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
74
Results
In all thyroid cancers and differentiated thyroid cancers, the group receiving Kampo medicine showed significantly longer overall survival (OS) and progression-free survival (PFS), and a significantly higher objective response rate (ORR). In anaplastic thyroid cancer, no significant differences were observed in any of these outcomes.
Results date posted
| 2026 | Year | 02 | Month | 22 | Day |
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
Completed
Date of protocol fixation
| 2022 | Year | 11 | Month | 10 | Day |
Date of IRB
| 2022 | Year | 12 | Month | 26 | Day |
Anticipated trial start date
| 2023 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 02 | Month | 22 | Day |
Last modified on
| 2026 | Year | 02 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069478
