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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000033862
Receipt No. R000038617
Scientific Title Feasibility study of Carbon-Ion Radiotherapy for Re-Irradiation of Locoregionally Recurrent Head and Neck Tumors
Date of disclosure of the study information 2018/10/01
Last modified on 2019/04/24

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Basic information
Public title Feasibility study of Carbon-Ion Radiotherapy for Re-Irradiation of Locoregionally Recurrent Head and Neck Tumors
Acronym Carbon-Ion Radiotherapy for Re-Irradiation
Scientific Title Feasibility study of Carbon-Ion Radiotherapy for Re-Irradiation of Locoregionally Recurrent Head and Neck Tumors
Scientific Title:Acronym Carbon-Ion Radiotherapy for Re-Irradiation
Region
Japan

Condition
Condition recurrent head and neck tumors
Classification by specialty
Radiology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the toxicity and efficacy of re-irradiation with CIRT for locoregionally recurrent head and neck tumors
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Toxicity
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
1 years-old <=
Age-upper limit
999 years-old >=
Gender Male and Female
Key inclusion criteria 1) patients who received re-irradiation with CIRT
2) measurable tumors
3) a performance status of 0-2
4) no systemic therapy, such as chemotherapy, within 1 month of commencing re-irradiation with CIRT
5) an estimated life expectancy of more than 6 months
Key exclusion criteria The presence of other primary cancers
Target sample size 48

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroaki Ikawa
Organization National Institutes for Quantum and Radiological Sciences and Technology
Division name Hospital of the National Institute of Radiological Sciences
Zip code
Address Anagawa 4-9-1, Inage-ku 263-8555 Chiba, Japan
TEL 043-206-3360
Email gbbd16cm@hotmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Kazuhiko Hayashi
Organization National Institutes for Quantum and Radiological Sciences and Technology
Division name Hospital of the National Institute of Radiological Sciences
Zip code
Address Anagawa 4-9-1, Inage-ku 263-8555 Chiba, Japan
TEL 043-206-3360
Homepage URL
Email gbbd16cm@hotmail.com

Sponsor
Institute Hospital of the National Institute of Radiological Sciences, National Institutes for Quantum and Radiological Sciences and Technology
Institute
Department

Funding Source
Organization Hospital of the National Institute of Radiological Sciences, National Institutes for Quantum and Radiological Sciences and Technology
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
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
2018 Year 10 Month 01 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications https://www.thegreenjournal.com/article/S0167-8140(19)30359-7/fulltext
Number of participants that the trial has enrolled 48
Results
The median follow-up period after re-irradiation was 27.1 months. Five patients (10.4%) developed Grade 3 acute toxicities and 18 (37.5%) developed Grade 3-5 late toxicities, including Grade 5 central nervous system necrosis in one patient. The 2-year local control, locoregional control, progression-free survival, and overall survival rates were 40.5, 33.5%, 29.4%, and 59.6%, respectively. 

Results date posted
2019 Year 04 Month 24 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
2019 Year 07 Month 01 Day
Baseline Characteristics
Participant flow
Adverse events
Five patients (10.4%) developed Grade 3 acute toxicities and 18 (37.5%) developed Grade3-5 late toxicities, including Grade 5 central nervous system necrosis in one patient. 
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2018 Year 08 Month 01 Day
Date of IRB
2018 Year 08 Month 30 Day
Anticipated trial start date
2018 Year 09 Month 30 Day
Last follow-up date
2018 Year 12 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information None

Management information
Registered date
2018 Year 08 Month 23 Day
Last modified on
2019 Year 04 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038617

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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