UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000053540 |
|---|---|
| Receipt number | R000061058 |
| Scientific Title | Outcomes of carbon ion radiotherapy and photon stereotactic body radiotherapy using Cyberknife for uveal melanoma |
| Date of disclosure of the study information | 2024/02/06 |
| Last modified on | 2024/02/05 08:53:24 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Outcomes of carbon ion radiotherapy and photon stereotactic body radiotherapy using Cyberknife for uveal melanoma
Acronym
Comparative Study of uveal melanoma
Scientific Title
Outcomes of carbon ion radiotherapy and photon stereotactic body radiotherapy using Cyberknife for uveal melanoma
Scientific Title:Acronym
Comparative Study of uveal melanoma
Region
| Japan | Asia(except Japan) |
Condition
Condition
uveal melanoma
Classification by specialty
| Ophthalmology | Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to compare the treatment outcomes of Cyberknife-based SBRT and CIRT for uveal melanoma patients. With CIRT recently introduced as a first in South Korea at Yonsei Medical Center, it has become a significant issue, and If the superiority of CIRT is demonstrated compared to conventional photon-based radiation therapy in the treatment of uveal melanoma, it could establish itself as a highly beneficial treatment option for these patients in the future.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
overall survival
Key secondary outcomes
Local control rate, adverse events, recurrence-free survival, eye preservation rate
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
Cases of choroidal malignant melanoma treated with carbon ion beam therapy at QST Hospital from April 1992 to October 2021, and cases treated with photon beam therapy using stereotactic irradiation with CyberKnife at Yonsei University Severance Hospital
Key exclusion criteria
(i) Cases in which the research subject or his/her representative refuses the use of clinical data for this study.
(ii) Recurrent cases, metastatic cases, cases with a history of irradiation to the head and neck region, and cases in which the comorbid invasive cancer has not remained disease-free for at least 3 years (excluding malignant tumors that do not significantly affect prognosis, such as thyroid cancer, MALT lymphoma, basal cell carcinoma of the skin, and early stage prostate cancer).
(iii) Patients who are lost to follow-up without at least one post-treatment follow-up visit.
Target sample size
380
Research contact person
Name of lead principal investigator
| 1st name | Masaru |
| Middle name | |
| Last name | Wakatsuki |
Organization
QST Hospital, National Institute for Quantum Science and Technology
Division name
Department of Diagnostic Radiology and Radiation Oncology
Zip code
263-8555
Address
4-9-1 Anagawa, Inage-ku, Chiba
TEL
043-206-3306
wakatsuki.masaru@qst.go.jp
Public contact
Name of contact person
| 1st name | Masaru |
| Middle name | |
| Last name | Wakatsuki |
Organization
QST Hospital, National Institute for Quantum Science and Technology
Division name
Department of Diagnostic Radiology and Radiation Oncology
Zip code
263-8555
Address
4-9-1 Anagawa, Inage-ku, Chiba
TEL
043-206-3306
Homepage URL
wakatsuki.masaru@qst.go.jp
Sponsor or person
Institute
National Institute for Quantum Science and Technology
Institute
Department
Personal name
Funding Source
Organization
National Institute for Quantum Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Institute for Quantum Science and Technology
Address
4-9-1 Anagawa, Inage-ku, Chiba
Tel
043-206-4706
helsinki@qst.go.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
国立研究開発法人量子科学技術研究開発機構QST病院
延世大学セブランス病院
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 02 | Month | 06 | 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
| 2024 | Year | 01 | Month | 22 | Day |
Date of IRB
| 2024 | Year | 01 | Month | 22 | Day |
Anticipated trial start date
| 2024 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 02 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This is a two-center, retrospective cohort study of patients with choroidal malignant melanoma treated with carbon ion beam therapy and stereotactic irradiation.
Management information
Registered date
| 2024 | Year | 02 | Month | 05 | Day |
Last modified on
| 2024 | Year | 02 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000061058
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
