UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027161 |
|---|---|
| Receipt number | R000030924 |
| Scientific Title | TOPICal Steroid versus placebo for the prevention of radiation dermatitis in head and neck cancer patients receiving chemoradiotherapy : a phase III, randomized, double-blinded trial |
| Date of disclosure of the study information | 2017/05/01 |
| Last modified on | 2017/11/13 16:25:23 |
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Basic information
Public title
TOPICal Steroid versus placebo for the prevention of radiation dermatitis
in head and neck cancer patients receiving chemoradiotherapy
: a phase III, randomized, double-blinded trial
Acronym
TOPICS study(J-SUPPORT 1602)
Scientific Title
TOPICal Steroid versus placebo for the prevention of radiation dermatitis
in head and neck cancer patients receiving chemoradiotherapy
: a phase III, randomized, double-blinded trial
Scientific Title:Acronym
TOPICS study(J-SUPPORT 1602)
Region
| Japan |
Condition
Condition
Locally Advanced Squamous Cell Carcinoma of the Head and Heck
Classification by specialty
| Medicine in general | Oto-rhino-laryngology | Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To clarify the prophylactic effect of topical steroid for radiation dermatitis in SCCHN patients receiving hcemoradiotherapy
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Phase III
Assessment
Primary outcomes
The frequency of radiation dermatitis grade2
Key secondary outcomes
The frequency of radiation dermatitis grade2
Treatment comliance
The frequency of local infection
The duration of grade2/3/4 radiation dermatitis
the rate of radiation dermatitis grade 2 at 2weeks after the end of radiotherapy
Toxicties(including PRO-CTCAE)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is considered as adjustment factor in dynamic allocation.
Blocking
YES
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Basic nursing care with Topical steroid
Start:develop to Grade 1 radiation dermatitis or recieced 30Gy of RT
Finish:Improved to Grade 1 radiation dermatitis or 8 weeks after start of this treatmen
Interventions/Control_2
Basic nursing care with Topical placebo
Start:develop to Grade 1 radiation dermatitis or recieced 30Gy of RT
Finish:Improved to Grade 1 radiation dermatitis or 8 weeks after start of this treatment
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
*PS 0-1
*Have a plan to receive CRT,CDDP/RT
*Have a plan to receive >66Gy radiotherapy
*Have a plan to receive >200mg/m2 CDDP during RT
*No diseases related with dermatitis
*Written in informed consent
Key exclusion criteria
Received steroid therapy before this treatment
Have an infection
Have allergies to Vaseline or topical steroid
Have severe complications
Target sample size
220
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Sadamoto Zenda |
Organization
National Cancer Center Hospital East
Division name
Department of Radiation Oncology
Zip code
Address
6-5-1 Kashiwanoha Kashiwa Chiba, Japan
TEL
04-7133-1111
szenda@east.ncc.go.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Sadamoto Zenda |
Organization
National Cancer Center Hospital East
Division name
Department of Radiation Oncology
Zip code
Address
6-5-1 Kashiwanoha Kashiwa Chiba, Japan
TEL
04-7133-1111
Homepage URL
szenda@east.ncc.go.jp
Sponsor or person
Institute
Department of Radiation Oncology, National Cancer Center Hospital East
Institute
Department
Personal name
Funding Source
Organization
The National Cancer Center Research and Development Fund ( 27-A-3)
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
Project Mirai Cancer Research Grants
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
| 2017 | Year | 05 | Month | 01 | 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
| 2017 | Year | 04 | Month | 27 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 05 | Month | 07 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 04 | Month | 27 | Day |
Last modified on
| 2017 | Year | 11 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030924
| 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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