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Name:
UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000027300
Receipt No. R000031231
Scientific Title Carbon-ion radiotherapy for solitary lymph node recurrence: a retrospective multicenter observational study
Date of disclosure of the study information 2017/05/10
Last modified on 2018/11/09

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Basic information
Public title Carbon-ion radiotherapy for solitary lymph node recurrence: a retrospective multicenter observational study
Acronym Carbon-ion radiotherapy for solitary lymph node recurrence: a retrospective multicenter observational study
Scientific Title Carbon-ion radiotherapy for solitary lymph node recurrence: a retrospective multicenter observational study
Scientific Title:Acronym Carbon-ion radiotherapy for solitary lymph node recurrence: a retrospective multicenter observational study
Region
Japan

Condition
Condition Solitary lymph node recurrence
Classification by specialty
Radiology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To assess the efficacy and toxicity of carbon-ion radiotherapy for solitary lymph node recurrence, retrospectively.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes 2-year local control, course-specfic survival, and overall survival rates.
Incidence of Grade 2 or worse late toxicities
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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Among patients who underwent carbon-ion radiotherapy in participating facilities between December 1996 and December 2015, patients who meet the following eligible criteria.
1) Patients who had diagnosed histologically or clinically as solitary lymph node recurrence.
2) Recurrence in single one lymph node region.
3) Lymph node recurrence could be included in an irradiation field.
4) There are no other recurrent lesions except the lymph node recurrence.
5) Tumor diameter could be measured by CT or MRI.
6) The age at starting of the carbon-ion radiotherapy was 20 years old and older.
7) Carbon-ion radiotherapy was administered to the lymph node recurrence.
Key exclusion criteria 1)Tumor invasion to GI tract.
2)Severe or active nfections in the irradiated area.
3)Severe concomitant illness.
Target sample size 310

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tadashi Kamada
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 043-206-3306
Email kamada.tadashi@qst.go.jp

Public contact
Name of contact person
1st name
Middle name
Last name Noriyuki Okonogi
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 043-206-3306
Homepage URL
Email okonogi.noriyuki@qst.go.jp

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 Gunma University Heavy Ion Medical Center
Hyogo Ion Beam Medical Center
Ion Beam Therapy Center, SAGA HIMAT Foundation
Name of secondary funder(s) None

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 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 Main results already published
Date of protocol fixation
2017 Year 03 Month 27 Day
Date of IRB
Anticipated trial start date
2017 Year 07 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information This is a retrospective multicenter observational study of carbon-ion radiotherapy for solitary lymph node recurrence.
Among patients who underwent carbon-ion radiotherapy in participating facilities between December 1996 and December 2015, patients who meet the following eligible criteria are enrolled in this study.
Eligible criteria:
1) Patients who had diagnosed histologically or clinically as solitary lymph node recurrence.
2) Recurrence in single one lymph node region.
3) Lymph node recurrence could be included in an irradiation field.
4) There are no other recurrent lesions except the lymph node recurrence.
5) Tumor diameter could be measured by CT or MRI.
6) The age at starting of the carbon-ion radiotherapy was 20 years old and older.
7) Carbon-ion radiotherapy was administered to the lymph node recurrence.
Exclusion criteria:
1)Tumor invasion to GI tract.
2)Severe or active nfections in the irradiated area.
3)Severe concomitant illness.

Management information
Registered date
2017 Year 05 Month 10 Day
Last modified on
2018 Year 11 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031231

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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