UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000001505
Receipt number R000001815
Scientific Title The phase II study of hypo-fractionated proton beam therapy for mucosal melanoma of the head and neck
Date of disclosure of the study information 2009/07/03
Last modified on 2015/11/13 10:23:46

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Basic information

Public title

The phase II study of hypo-fractionated proton beam therapy for mucosal melanoma of the head and neck

Acronym

MM proton P-II

Scientific Title

The phase II study of hypo-fractionated proton beam therapy for mucosal melanoma of the head and neck

Scientific Title:Acronym

MM proton P-II

Region

Japan


Condition

Condition

Mucosal melanoma of the head and neck

Classification by specialty

Dermatology Oto-rhino-laryngology Radiology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To clarify a clinical profile of proton beam therapy for mucosal melanoma of the head and neck

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Local control rate

Key secondary outcomes

Overall survival
Acute toxicity
Late toxicity


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Device,equipment

Interventions/Control_1

Proton beam therapy 60GyE/15fr/5w

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.Histologically confirmed mucosal melanoma
2.nasal or paranasal mucosal melanoma
3.N0 and M0
4.PS(ECOG):0-2
5.adequate organ function

Key exclusion criteria

1.with active other carcinoma
2.with mental disorder
3.recieve systemic steroid therapy
4.with active infectious disease

Target sample size

35


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Sadamoto Zenda

Organization

National Cancer Center Hospital East

Division name

Division of Radiation Oncology

Zip code


Address

6-5-1 Kashiwanoha Kashiwa chiba, Japan

TEL

04-7133-1111

Email

szenda@east.ncc.go.jp


Public contact

Name of contact person

1st name
Middle name
Last name Sadamoto Zenda

Organization

National Cancer Center Hospital East

Division name

Division of Radiation Oncology

Zip code


Address

6-5-1 Kashiwanoha Kashiwa Chiba

TEL

04-7133-1111

Homepage URL


Email

szenda@east.ncc.go.jp


Sponsor or person

Institute

National Cancer Center Hospital East
Division of Radiation Oncology

Institute

Department

Personal name



Funding Source

Organization

Self funding

Organization

Division

Category of Funding Organization

Self funding

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

2009 Year 07 Month 03 Day


Related information

URL releasing protocol


Publication of results

Published


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

2008 Year 06 Month 13 Day

Date of IRB


Anticipated trial start date

2009 Year 07 Month 01 Day

Last follow-up date

2015 Year 07 Month 01 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2008 Year 11 Month 13 Day

Last modified on

2015 Year 11 Month 13 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001815


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name