UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000026736
Receipt No. R000030693
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
Date of disclosure of the study information 2017/03/30
Last modified on 2017/03/28

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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 No longer recruiting
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
2017 Year 03 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030693

Research Plan
Registered date Registrant File name

Research case data specifications
Registered date Registrant File name

Research case data
Registered date Registrant File name


For inquiries about the use of UMIN clinical trial registration system, use this contact form .Fort other inquiries, use this contact form