UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000050563 |
|---|---|
| Receipt number | R000057535 |
| Scientific Title | Conversion Surgery After Molecular Targeted Therapy for Unresectable Thyroid Cancer |
| Date of disclosure of the study information | 2023/03/17 |
| Last modified on | 2024/04/19 09:41:09 |
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Basic information
Public title
Conversion Surgery After Molecular Targeted Therapy for Unresectable Thyroid Cancer
Acronym
Conversion Surgery for Unresectable Thyroid Cancer
Scientific Title
Conversion Surgery After Molecular Targeted Therapy for Unresectable Thyroid Cancer
Scientific Title:Acronym
Conversion Surgery for Unresectable Thyroid Cancer
Region
| Japan |
Condition
Condition
Unresectable Thyroid Cancer
Classification by specialty
| Endocrine surgery |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To investigate the efficacy and safety of conversion surgery after molecular targeted therapy for locally advanced unresectable thyroid cancer.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Phase II
Assessment
Primary outcomes
Rate of conversion surgery
Key secondary outcomes
Rate of local resection (R0/1/2), Locoregional progression-free survival, Overall survival, Progression-free survival, Treatment-related death, Perioperative complications, and Combined resection of other organs.
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
| Maneuver |
Interventions/Control_1
Conversion surgery is performed for local control if the tumor is resectable after molecular targeted therapy approved in Japan (i.e., Selpercatinib, Lenvatinib, Sorafenib, or dabrafenib/trametinib).
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
| 12 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Pathologic findings supporting papillary thyroid carcinoma, follicular thyroid carcinoma, poorly differentiated carcinoma, or medullary thyroid carcinoma
2) The tumor was considered to be unresectable by CT scan and/or palpation
3) Regardless of distant metastasis/nonregional lymph node metastasis status
4) At least 12 years of age on the day of signing an informed consent
5) Willing and able to provide written informed consent signed by the study patient (or legally acceptable representative if applicable)
Key exclusion criteria
1) Recurrent case
2) The cases with tumor invasion reaching into tracheal/esophageal/laryngeal/ pharyngeal lumen (i.e., the superficial layers of these organs) or large vessels.
3) Having any contraindications for all molecularly targeted drugs planned to use.
4) Patients unable to withstand surgery.
5) Psychiatric disease
6) Eastern Cooperative Oncology Group performance status (PS) of 3 or 4
7) Pregnancy or lactation
8) Any other cases that are regarded as inadequate for study enrollment by the investigator.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Saito |
| Middle name | |
| Last name | Yoshiyuki |
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
y-saito@ito-hospital.jp
Public contact
Name of contact person
| 1st name | Saito |
| Middle name | |
| Last name | Yoshiyuki |
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
y-saito@ito-hospital.jp
Sponsor or person
Institute
Ito Hospital
Institute
Department
Personal name
Funding Source
Organization
Ito 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
Ito Hospital
Address
4-3-6, Jingumae, shibuya-ku, Tokyo, Japan
Tel
03-3402-7411
k-sugino@ito-hospital.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 | 03 | Month | 17 | 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
Open public recruiting
Date of protocol fixation
| 2023 | Year | 03 | Month | 10 | Day |
Date of IRB
| 2023 | Year | 03 | Month | 11 | Day |
Anticipated trial start date
| 2023 | Year | 03 | Month | 17 | Day |
Last follow-up date
| 2032 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 03 | Month | 11 | Day |
Last modified on
| 2024 | Year | 04 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000057535
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| Registered date | File name |
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| Registered date | File name |
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