UMIN-CTR 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 | 2026/08/10 13:08:14 |
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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
Unpublidhed
Publication of results
Published
Result
URL related to results and publications
https://pmc.ncbi.nlm.nih.gov/articles/PMC12615358/
Number of participants that the trial has enrolled
346
Results
A total of 282 and 64 patients were treated with CIRT and SABR, respectively. After propensity score matching, 5-year PFS was significantly higher with CIRT than with SABR (69.0% vs. 56.5%, p = 0.024). CIRT also reduced local recurrence (5.6% vs. 13.4%, p = 0.025) and enucleation (8.5% vs. 24.2%, p < 0.001). SABR, older age, and larger tumor size were adverse prognostic factors. Visual acuity preservation was significantly better with CIRT (p = 0.0045).
Results date posted
| 2026 | Year | 08 | Month | 10 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
The study included patients with localized choroidal melanoma who underwent CIRT at QST Hospital or SABR at Yonsei University Severance Hospital between April 2001 and October 2021.
Participant flow
We conducted a retrospective registry of patients with localized choroidal melanoma who underwent CIRT at QST Hospital and SABR at Yonsei University Severance Hospital between April 2001 and October 2021.
Adverse events
Across the entire cohort, 21 patients (7.4%) in the CIRT group and 14 patients (21.9%) in the SABR group underwent enucleation. In the PSM cohort, 16 patients (8.3%) in the CIRT group and 14 patients (21.9%) in the SABR group underwent enucleation. The 5-year cumulative enucleation rate was higher in the SABR group (CIRT: 8.5%, 95% CI, 4.2%-12.9% vs. SABR: 24.2%, 95% CI, 12.9%-35.4%, P < 0.001). Regarding the cause of enucleation, cancer progression was the primary reason in the CIRT group (10 of 16 patients, 62.5%), whereas treatment-related toxicity was the primary reason in the SABR group (9 of 14 patients, 64.3%).
Outcome measures
The median follow-up periods for the CIRT and SABR groups were 70.2 months and 51.9 months, respectively. In the entire patient cohort, CIRT demonstrated superior outcomes to SABR in all respects. The survival outcomes for the two groups in the PSM cohort are shown below. Although no statistically significant difference was observed in 5-year OS (CIRT: 81.0%, 95% CI, 75.2%-87.2% vs. SABR: 70.9%, 95% CI, 60.0%-83.9%, P = 0.1), a survival benefit was observed in the CIRT group with regard to PFS. The 5-year PFS was 69.0% (95% CI, 62.4%-76.3%) in the CIRT group and 56.5% (95% CI, 45.0%-71.0%) in the SABR group (P = 0.024). Furthermore, the CIRT group had a significantly lower local recurrence rate compared to the SABR group. The 5-year local recurrence rate was 5.6% (95% CI, 2.0%-9.3%) in the CIRT group and 13.4% (95% CI, 4.6%-22.2%) in the SABR group (P = 0.025). No significant difference was observed between the two groups in the 5-year distant recurrence rate (CIRT: 27.5%, 95% CI, 20.6%-34.3% vs. SABR: 35.0%, 95% CI, 22.1%-47.9%; P = 0.13). Distant metastases were observed in a total of 85 patients. Among these patients, the liver was the most common site of recurrence (n = 60, 70.6%), followed by the lung (n = 12, 14.1%). Sixty-eight patients died, the majority of whom died due to disease progression (n = 57, 83.8%). The primary cause of death was extensive liver metastases.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
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
| 2026 | Year | 08 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061058
