UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019717 |
|---|---|
| Receipt number | R000022735 |
| Scientific Title | The study to examine the appropriate skin dose in intensity modulated radiotherapy with cetuximab |
| Date of disclosure of the study information | 2015/11/10 |
| Last modified on | 2021/05/14 12:17:02 |
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Basic information
Public title
The study to examine the appropriate skin dose in intensity modulated radiotherapy with cetuximab
Acronym
The study to examine the appropriate skin dose in intensity modulated radiotherapy with cetuximab
Scientific Title
The study to examine the appropriate skin dose in intensity modulated radiotherapy with cetuximab
Scientific Title:Acronym
The study to examine the appropriate skin dose in intensity modulated radiotherapy with cetuximab
Region
| Japan |
Condition
Condition
Head and neck cancer
Classification by specialty
| Hematology and clinical oncology | Oto-rhino-laryngology | Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To examine the appropriate skin dose with skin clip in intensity modulated radiotherapy with conccurent use of cetuximab and to evaluate the efficacy.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase I,II
Assessment
Primary outcomes
Phase I: Acute skin toxicity
Phase II: Response rate(at the 8 weeks after radiotherapy)
Key secondary outcomes
Locoregional progression free survival
Progression free survival
Overall survival
Adverse events
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine | Other |
Interventions/Control_1
Intensity modulated radiotherapy (more than 60 Gy) with concurrent use of cetuximab
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Locally advanced head and neck carcinoma
Concurrent use of cetuximab
Intensity modulated radiotherapy
The number of lymph node region irradiated is equal to or more than 2
Age over 20
PS 0-2
Written informed consent
Key exclusion criteria
Severe coexisting disease
Synchronous malignancies
Pregnancy, possible pregnancy
Target sample size
39
Research contact person
Name of lead principal investigator
| 1st name | Jun |
| Middle name | |
| Last name | Itami |
Organization
National Cancer Center Hospital, Japan
Division name
Department of Radiation Oncology
Zip code
1040045
Address
5-1-1, Tsukiji, Chuo-ku, Tokyo
TEL
03-3542-2511
jitami@ncc.go.jp
Public contact
Name of contact person
| 1st name | Koji |
| Middle name | |
| Last name | Inaba |
Organization
National Cancer Center Hospital, Japan
Division name
Department of Radiation Oncology
Zip code
1040045
Address
5-1-1, Tsukiji, Chuo-ku, Tokyo
TEL
03-3542-2511
Homepage URL
koinaba@ncc.go.jp
Sponsor or person
Institute
National Cancer Center Hospital, Japan
Institute
Department
Personal name
Funding Source
Organization
None
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
National Cancer Center Institutional Review Board
Address
5-1-1 Tsukiji, Chuo-ku Tokyo, 104-0045 Japan
Tel
03-3542-2511
NCC_IRBoffice@ml.res.ncc.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
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 11 | Month | 10 | 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
| 2015 | Year | 10 | Month | 16 | Day |
Date of IRB
| 2015 | Year | 10 | Month | 16 | Day |
Anticipated trial start date
| 2015 | Year | 11 | Month | 10 | Day |
Last follow-up date
| 2020 | Year | 10 | Month | 28 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 11 | Month | 09 | Day |
Last modified on
| 2021 | Year | 05 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022735
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
