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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000031155
Receipt No. 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 2019/02/06

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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
Middle name
Last name Hiro Sato
Organization Gunma University Graduate School of Medicine
Division name Department of Radiation Oncology
Zip code
Address 3-39-22 Showa-machi, Maebashi, Gunma 371-8511 JAPAN
TEL 027-220-8383
Email h-sato0808@hotmail.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Daijiro Kobayashi
Organization Kanto Neurosurgical Hospital
Division name Cyber Center
Zip code
Address 1120, Dai, Kumagaya, Saitama 360-0804 JAPAN
TEL 048-521-3133
Homepage URL
Email m07201029@gmail.com

Sponsor
Institute Kanto Neurosurgical Hospital
Institute
Department

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
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 03 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 Enrolling by invitation
Date of protocol fixation
2018 Year 02 Month 05 Day
Date of IRB
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 02 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035584

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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