UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000038950
Receipt number R000044416
Scientific Title A retrospective multicenter study of re-irradiation using carbon-ions for recurrent head and neck cancers
Date of disclosure of the study information 2019/12/23
Last modified on 2020/12/24 19:39:30

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Basic information

Public title

A retrospective multicenter study of re-irradiation using carbon-ions for recurrent head and neck cancers

Acronym

A retrospective multicenter study of re-irradiation using carbon-ions for recurrent head and neck cancers

Scientific Title

A retrospective multicenter study of re-irradiation using carbon-ions for recurrent head and neck cancers

Scientific Title:Acronym

A retrospective multicenter study of re-irradiation using carbon-ions for recurrent head and neck cancers

Region

Japan


Condition

Condition

Recurrent head and neck cancers after photon radiotherapy

Classification by specialty

Oto-rhino-laryngology Radiology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the safety and efficacy of re-irradiation using carbon-ions for recurrent head and neck cancers after photon radiotherapy.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

2-year overall survival

Key secondary outcomes

Loco-regional control rate, Metastasis rate, Progression free survival rate, Greater than grade 3 acute adverse effect, Greater than grade 2 late adverse effect


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

1 Not applicable <=

Age-upper limit

120 Not applicable >=

Gender

Male and Female

Key inclusion criteria

The candidates are patients who underwent re-irradiation using carbon-ions for recurrent head and neck cancers in Japan between November 2003 and March 2019.

Key exclusion criteria

Patients refusing the use of clinical data.

Target sample size

60


Research contact person

Name of lead principal investigator

1st name Koto
Middle name
Last name Masashi

Organization

National Institutes for Quantum and Radiological Sciences and Technology

Division name

National Institute of Radiological Sciences

Zip code

263-8555

Address

4-9-1 Anagawa, Inage-ku, Chiba

TEL

043-206-3306

Email

koto.masashi@qst.go.jp


Public contact

Name of contact person

1st name Certified Review Board
Middle name
Last name National Institutes for Quantum and Radiological Science and Technology

Organization

National Institutes for Quantum and Radiological Science and Technology

Division name

Certified Review Board

Zip code

263-0024

Address

4-9-1, Anagawa, Inage, Chiba

TEL

0432063306

Homepage URL


Email

helsinki@qst.go.jp


Sponsor or person

Institute

National Institute of Radiological Sciences

Institute

Department

Personal name



Funding Source

Organization

National Institute of Radiological Sciences

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization



Other related organizations

Co-sponsor

Gunma University Heavy Ion Medical Center
Hyogo Ion Beam Medical Center
SAGA HIMAT

Name of secondary funder(s)



IRB Contact (For public release)

Organization

National Institutes for Quantum and Radiological Science and Technology Certified Review Board

Address

4-9-1, Anagawa, Inage, Chiba

Tel

0432063306

Email

helsinki@qst.go.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

2019 Year 12 Month 23 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

Completed

Date of protocol fixation

2019 Year 09 Month 23 Day

Date of IRB

2019 Year 10 Month 16 Day

Anticipated trial start date

2020 Year 04 Month 01 Day

Last follow-up date

2020 Year 07 Month 30 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded

2020 Year 12 Month 31 Day


Other

Other related information

nothing


Management information

Registered date

2019 Year 12 Month 21 Day

Last modified on

2020 Year 12 Month 24 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044416


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name