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

Email

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


Email

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


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

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name