UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000007373
Receipt number R000008682
Scientific Title Evaluation of mimimally invasive palliative therapy by Transcatheter arterial chemoembolization for unresectable recurrent head and neck cancer
Date of disclosure of the study information 2012/02/24
Last modified on 2012/02/24 15:37:26

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Basic information

Public title

Evaluation of mimimally invasive palliative therapy by
Transcatheter arterial chemoembolization
for unresectable recurrent head and neck cancer

Acronym

Evaluation of TACE
for unresectable recurrent head and neck cancer

Scientific Title

Evaluation of mimimally invasive palliative therapy by
Transcatheter arterial chemoembolization
for unresectable recurrent head and neck cancer

Scientific Title:Acronym

Evaluation of TACE
for unresectable recurrent head and neck cancer

Region

Japan


Condition

Condition

Head and neck cancer

Classification by specialty

Oto-rhino-laryngology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

Evaluation of TACE unresectable recurrent head and neck cancer with bleeding

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

efficacy of hemostasis,
duration of hemostasis,
duration of hospitalization after treatment,
pain control,

Key secondary outcomes



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

Medicine Maneuver

Interventions/Control_1

TACE

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, Patient age 20 years and above
2, unresectable recurrent head and neck cancer after common therapy
3, bleeding for cutaneous and mucosal invasion or high risk of bleeding
4, no other effective treatment
5, Patients who were provided written informed consent

Key exclusion criteria

1, pregnancy or lactating women or women with suspected pregnancy
2, possibility of the remarkabke phisical damage by this treatment
3, Patient judged by the investigator to be unfit to be enrolled into the study

Target sample size

5


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Junkichi Yokoyama

Organization

Juntendo university school of medicine

Division name

Department of Otolaryngology, head and neck surgery

Zip code


Address

2-1-2, Hongo, Bunkyou-ku, Tokyo

TEL


Email



Public contact

Name of contact person

1st name
Middle name
Last name

Organization

Juntendo university school of medicine

Division name

Department of Otolaryngology, head and neck surgery

Zip code


Address


TEL

03-3813-1605

Homepage URL


Email



Sponsor or person

Institute

Juntendo university school of medicine

Institute

Department

Personal name



Funding Source

Organization

Health and Labor Science Reserch Grant for Clinical Cancer Reserch

Organization

Division

Category of Funding Organization

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

2012 Year 02 Month 24 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

Enrolling by invitation

Date of protocol fixation

2012 Year 02 Month 21 Day

Date of IRB


Anticipated trial start date

2012 Year 03 Month 01 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2012 Year 02 Month 24 Day

Last modified on

2012 Year 02 Month 24 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008682


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name