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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000027161
Receipt No. 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

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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
Email 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
Email szenda@east.ncc.go.jp

Sponsor
Institute Department of Radiation Oncology, National Cancer Center Hospital East
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030924

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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