UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026736 |
|---|---|
| Receipt number | R000030693 |
| Scientific Title | Clinical impact of re-irradiation with carbon-ion radiotherapy for lymph node recurrence of gynecological cancers after definitive radiotherapy |
| Date of disclosure of the study information | 2017/03/30 |
| Last modified on | 2018/09/27 17:58:25 |
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Basic information
Public title
Clinical impact of re-irradiation with carbon-ion radiotherapy for lymph node recurrence of gynecological cancers after definitive radiotherapy
Acronym
Clinical impact of re-irradiation with C-ion RT for LN recurrence of gynecological cancers after definitive RT
Scientific Title
Clinical impact of re-irradiation with carbon-ion radiotherapy for lymph node recurrence of gynecological cancers after definitive radiotherapy
Scientific Title:Acronym
Clinical impact of re-irradiation with C-ion RT for LN recurrence of gynecological cancers after definitive RT
Region
| Japan |
Condition
Condition
Lymph node recurrence of gynecological cancers
Classification by specialty
| Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study was to evaluate the safety and efficacy of re-irradiation with carbon-ion radiotherapy (C-ion RT) for lymph node recurrence of gynecological cancers after definitive radiotherapy.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
2-year overall survival rate
Key secondary outcomes
2-year local control rate
Toxicities (acute and late)
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients treated with C-ion RT.
Patients had recurrent tumor from gynecological cancer after definitive radiotherapy.
There was only one lesion of recurrence within or at the edge of the previously irradiated field.
The tumor was unresectable.
Key exclusion criteria
With other active malignancy
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masaru Wakatsuki |
Organization
Jichi Medical University
Division name
Department of Radiology
Zip code
Address
3311-1, Yakushiji, Simotsuke-city, Tochigi 329-0498, Japan
TEL
0285-58-7161
wakkun100@yahoo.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masaru Wakatsuki |
Organization
Jichi Medical University
Division name
Department of Radiology,
Zip code
Address
3311-1, Yakushiji, Simotsuke-city, Tochigi 329-0498, Japan
TEL
0285-58-7161
Homepage URL
wakkun100@yahoo.co.jp
Sponsor or person
Institute
The Research Project with Heavy Ions at the National Institute of radiological Sciences (NIRS)-Heavy Ion Medical Accelerator in Chiba (HIMAC).
Institute
Department
Personal name
Funding Source
Organization
Self funding
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
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 | 03 | Month | 30 | 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 | 28 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 03 | Month | 29 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Retrospective study
Management information
Registered date
| 2017 | Year | 03 | Month | 28 | Day |
Last modified on
| 2018 | Year | 09 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030693
