UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048036 |
|---|---|
| Receipt number | R000054747 |
| Scientific Title | Prospective Registry Observational Study of Carbon Ion Radiation Therapy in Mucosal Malignant Melanoma of the Head and Neck |
| Date of disclosure of the study information | 2022/06/13 |
| Last modified on | 2023/02/17 16:32:01 |
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Basic information
Public title
Prospective Registry Observational Study of Carbon Ion Radiation Therapy in Mucosal Malignant Melanoma of the Head and Neck
Acronym
Prospective Registry Observational Study of Carbon Ion Radiation Therapy in Mucosal Malignant Melanoma of the Head and Neck
Scientific Title
Prospective Registry Observational Study of Carbon Ion Radiation Therapy in Mucosal Malignant Melanoma of the Head and Neck
Scientific Title:Acronym
Prospective Registry Observational Study of Carbon Ion Radiation Therapy in Mucosal Malignant Melanoma of the Head and Neck
Region
| Japan |
Condition
Condition
Mucosal Malignant Melanoma of the Head and Neck
Classification by specialty
| Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To determine the efficacy of an acceptable treatment approach that allows the use of immune checkpoint inhibitors after carbon ion radiotherapy for mucosal malignant melanoma of the head and neck
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The overall survival rate will be evaluated between two groups, one with and the other without immune checkpoint inhibitors administered within the usual care after carbon ion radiotherapy.
Key secondary outcomes
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
| 16 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Patients with histologically proven mucosal malignant melanoma of the head and neck region.
2) Patients with N0M0 (TNM classification, 8th edition).
3) Patients with measurable lesions.
4) Patients who are scheduled to receive heavy particle radiotherapy.
5) Patients who are 16 years of age or older.
6) Patients whose Performance Status (PS) is 0-2.
7) Patients who have been informed of the name and condition of their disease and have the capacity to consent.
(For minors, the consent of a legal guardian is required.)
Key exclusion criteria
1) Patients with a history of radiation therapy to the area to be treated.
2) Patients with active and refractory infection at the irradiated site.
3) Patients with serious complications (uncontrolled diabetes mellitus, myocardial infarction requiring emergency treatment, unstable angina, uncontrolled arrhythmia, bleeding tendency due to untreated bleeding disorder, collagen disease requiring steroid administration, etc.)
4) Patients with active multiple cancers (simultaneous multiple cancers and iatrogenic multiple cancers with a disease-free interval of 5 years or less). However, lesions equivalent to intraepithelial or intramucosal carcinoma that are considered curable by local treatment are not included in the active overlapping cancers.
5) Other patients who are deemed medically, psychologically, or due to other factors to be inappropriate by the physician in charge.
Target sample size
25
Research contact person
Name of lead principal investigator
| 1st name | Tatsuya |
| Middle name | |
| Last name | Ohno |
Organization
Gunma University Graduate School of Medicine
Division name
Department of Radiation Oncology
Zip code
3718511
Address
3-39-22 Showa-machi, Maebashi, Gunma
TEL
027-220-8383
tohno@gunma-u.ac.jp
Public contact
Name of contact person
| 1st name | Atsushi |
| Middle name | |
| Last name | Musha |
Organization
Gunma University
Division name
Heavy Ion Medical Center
Zip code
3718511
Address
3-39-22 Showa-machi, Maebashi, Gunma
TEL
027-220-8378
Homepage URL
musha@gunma-u.ac.jp
Sponsor or person
Institute
Gunma University
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Gunma University Hospital Clinical Research Review Board
Address
3-39-15 Showa-machi, Maebashi, Gunma
Tel
027-220-8740
gunmaciru-office@umin.ac.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
| 2022 | Year | 06 | Month | 13 | 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
| 2022 | Year | 06 | Month | 07 | Day |
Date of IRB
| 2022 | Year | 05 | Month | 19 | Day |
Anticipated trial start date
| 2022 | Year | 06 | Month | 13 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
none
Management information
Registered date
| 2022 | Year | 06 | Month | 12 | Day |
Last modified on
| 2023 | Year | 02 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054747
