UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007939 |
|---|---|
| Receipt number | R000009349 |
| Scientific Title | Prospective study of efficacy and safety of carbon ion radiotherapy combined with chemotherapy for head and neck melanoma |
| Date of disclosure of the study information | 2012/05/13 |
| Last modified on | 2019/10/25 21:22:40 |
* 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
Prospective study of efficacy and safety of carbon ion radiotherapy combined with chemotherapy for head and neck melanoma
Acronym
Carbon ion radiotherapy combined with chemotherapy for head and neck melanoma
Scientific Title
Prospective study of efficacy and safety of carbon ion radiotherapy combined with chemotherapy for head and neck melanoma
Scientific Title:Acronym
Carbon ion radiotherapy combined with chemotherapy for head and neck melanoma
Region
| Japan |
Condition
Condition
Head and neck melanoma
Classification by specialty
| Oto-rhino-laryngology | Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To confirm efficacy and safety of carbon ion radiotherapy combined with chemotherapy for head and neck melanoma
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Overall survival rate at 3 years
Key secondary outcomes
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
| Medicine | Maneuver |
Interventions/Control_1
Carbon ion radiotherapy combined with chemotherapy
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Histologically confirmed head and neck melanoma
2) N0M0 (UICC 7th)
3) Measurable tumor
4) Age 16-80
5) No severe organ dysfunction
6) PS 0-2
7) Informed consent was given
Key exclusion criteria
1) Past history of irradiation to the target
2) Past history of chemotherapy before treatment
3) Uncontrolled infection
4) Severe concomitant disease
5) Active double cancers
6) Other medical or psychological unsuitable reasons
Target sample size
45
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takashi Nakano |
Organization
Gunma University
Division name
Gunma University Heavy Ion Medical Center
Zip code
Address
3-39-22 Showa, Maebashi, Gunma 371-8511
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Gunma University
Division name
Gunma University Heavy Ion Medical Center
Zip code
Address
TEL
027-220-8378
Homepage URL
Sponsor or person
Institute
Gunma University Heavy Ion Medical Center
Institute
Department
Personal name
Funding Source
Organization
MEXT
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2012 | Year | 05 | 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
Completed
Date of protocol fixation
| 2012 | Year | 02 | Month | 13 | Day |
Date of IRB
| 2012 | Year | 03 | Month | 29 | Day |
Anticipated trial start date
| 2012 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 02 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2012 | Year | 05 | Month | 13 | Day |
Last modified on
| 2019 | Year | 10 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009349
