UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031155 |
|---|---|
| Receipt number | R000035584 |
| Scientific Title | Efficacy and feasibility of re-irradiation with CyberKnife radiosurgery and stereotactic radiotherapy as a salvage treatment for in-field neck lymph node recurrences after conventional radiotherapy: a retrospective study |
| Date of disclosure of the study information | 2018/03/01 |
| Last modified on | 2019/12/25 09:37:10 |
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Basic information
Public title
Efficacy and feasibility of re-irradiation with CyberKnife radiosurgery and stereotactic radiotherapy as a salvage treatment for in-field neck lymph node recurrences after conventional radiotherapy: a retrospective study
Acronym
Efficacy and feasibility of re-irradiation with CyberKnife radiosurgery and stereotactic radiotherapy as a salvage treatment for in-field neck lymph node recurrences after conventional radiotherapy: a retrospective study
Scientific Title
Efficacy and feasibility of re-irradiation with CyberKnife radiosurgery and stereotactic radiotherapy as a salvage treatment for in-field neck lymph node recurrences after conventional radiotherapy: a retrospective study
Scientific Title:Acronym
Efficacy and feasibility of re-irradiation with CyberKnife radiosurgery and stereotactic radiotherapy as a salvage treatment for in-field neck lymph node recurrences after conventional radiotherapy: a retrospective study
Region
| Japan |
Condition
Condition
neck lymph node recurrences
Classification by specialty
| Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To assess the efficacy and toxicity of stereotactic radiotherapy using CyberKnife for in-field lymph node recurrences after radiotherapy, retrospectively.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Incidence of acute toxicities
Key secondary outcomes
One-year local control, incidence of late toxicities, and overall survival rates.
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
1) diagnosed as recurrence from clinical course
2) evaluable lesions detected by CT or MRI
3) performance status 0 - 2
4) recurrence in the previous irradiation site
Key exclusion criteria
recurrences out-field radiotherapy
Target sample size
19
Research contact person
Name of lead principal investigator
| 1st name | Hiro |
| Middle name | |
| Last name | Sato |
Organization
Gunma University Graduate School of Medicine
Division name
Department of Radiation Oncology
Zip code
371-8511
Address
3-39-22 Showa-machi, Maebashi, Gunma 371-8511 JAPAN
TEL
027-220-8383
h-sato0808@hotmail.co.jp
Public contact
Name of contact person
| 1st name | Daijiro |
| Middle name | |
| Last name | Kobayashi |
Organization
Kanto Neurosurgical Hospital
Division name
Cyber Center
Zip code
360-0804
Address
1120, Dai, Kumagaya, Saitama 360-0804 JAPAN
TEL
048-521-3133
Homepage URL
m07201029@gmail.com
Sponsor or person
Institute
Kanto Neurosurgical Hospital
Institute
Department
Personal name
Funding Source
Organization
Kanto Neurosurgical Hospital
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
Kanto Neurosurgical Hospital
Address
1120, Dai, Kumagaya, Saitama 360-0804 JAPAN
Tel
048-521-3133
kantou@ps.ksky.ne.jp
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 | 03 | Month | 01 | Day |
Related information
URL releasing protocol
https://www.mdpi.com/2077-0383/8/11/1911
Publication of results
Published
Result
URL related to results and publications
https://www.mdpi.com/2077-0383/8/11/1911
Number of participants that the trial has enrolled
16
Results
The one-year local control (LC) and overall survival rates were 81% and 71%, respectively.
Results date posted
| 2019 | Year | 12 | Month | 25 | Day |
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
Completed
Date of protocol fixation
| 2018 | Year | 02 | Month | 05 | Day |
Date of IRB
| 2018 | Year | 02 | Month | 05 | Day |
Anticipated trial start date
| 2018 | Year | 02 | Month | 05 | Day |
Last follow-up date
| 2019 | Year | 02 | Month | 06 | Day |
Date of closure to data entry
| 2019 | Year | 02 | Month | 06 | Day |
Date trial data considered complete
| 2019 | Year | 02 | Month | 06 | Day |
Date analysis concluded
| 2019 | Year | 02 | Month | 09 | Day |
Other
Other related information
1) diagnosed as recurrence from clinical course
2) evaluable lesions detected by CT or MRI
3) performance status 0 - 2
4) recurrence in the previous irradiation site
Management information
Registered date
| 2018 | Year | 02 | Month | 05 | Day |
Last modified on
| 2019 | Year | 12 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035584
| Research Plan | |
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| Registered date | File name |
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