UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Clinical impact of re-irradiation with carbon-ion radiotherapy for lymph node recurrence of gynecological cancers after definitive radiotherapy
Title of the study (Brief title)	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	Masaru Wakatsuki
Organization	Jichi Medical University
Division name	Department of Radiology
Address	3311-1, Yakushiji, Simotsuke-city, Tochigi 329-0498, Japan
TEL	0285-58-7161
Email	wakkun100@yahoo.co.jp

Public contact
Name of contact person	Masaru Wakatsuki
Organization	Jichi Medical University
Division name	Department of Radiology,
Address	3311-1, Yakushiji, Simotsuke-city, Tochigi 329-0498, Japan
TEL	0285-58-7161
Homepage URL
Email	wakkun100@yahoo.co.jp

Sponsor
Institute	The Research Project with Heavy Ions at the National Institute of radiological Sciences (NIRS)-Heavy Ion Medical Accelerator in Chiba (HIMAC).
Institute
Department

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)

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

Progress
Recruitment status	Main results already published
Date of protocol fixation	2017 Year 03 Month 28 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000030693