UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000003623
Receipt number R000004390
Scientific Title A phase II trial of endoscopic submucosal dissection (ESD) for superficial pharyngeal cancer
Date of disclosure of the study information 2010/05/17
Last modified on 2020/05/25 08:29:24

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Basic information

Public title

A phase II trial of endoscopic submucosal dissection (ESD) for superficial pharyngeal cancer

Acronym

A phase II trial of ESD for superficial pharyngeal cancer

Scientific Title

A phase II trial of endoscopic submucosal dissection (ESD) for superficial pharyngeal cancer

Scientific Title:Acronym

A phase II trial of ESD for superficial pharyngeal cancer

Region

Japan


Condition

Condition

superficial pharyngeal cancer

Classification by specialty

Gastroenterology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the efficacy and safety of ESD for superficial pharyngeal cancer.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Complete en block resection rate

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

Maneuver

Interventions/Control_1

Endoscopic submucosal dissection (ESD)

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

Superficial pharyngeal carcinoma confined to subepithelial lesion without lymphnode metastasis.

Key exclusion criteria

1)Patients with hematologicalabnormality
2)Active synchronous or metachronous malignancy
3)Patients with severe organ failure
4)Others who were thought to be unsuitable by the investigator.
5)Patients who underwent radiation therapy.

Target sample size

30


Research contact person

Name of lead principal investigator

1st name Noboru
Middle name
Last name Noboru

Organization

Osaka Medical Center for Cancer and Cardiovascular Diseases

Division name

Gastrointestinal Oncology

Zip code

537-8511

Address

1-3-3 Nakamichi, Higashinariku, Osaka 537-8511 Japan

TEL

06-6972-1181

Email

hanaoka-no@mc.pref.osaka.jp


Public contact

Name of contact person

1st name Noboru
Middle name
Last name Hanaoka

Organization

Osaka Medical Center for Cancer and Cardiovascular Diseases

Division name

Gastrointestinal Oncology

Zip code

537-8511

Address

nakamichi higashinari-ku 1-3-3 Osaka, Japan

TEL

06-672-1181

Homepage URL


Email

hanaoka-no@mc.pref.osaka.jp


Sponsor or person

Institute

Osaka Medical Center for Cancer and Cardiovascular Diseases

Institute

Department

Personal name



Funding Source

Organization

None

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

Osaka Medical Center for Cancer and Cardiovascular Diseases

Address

Nakamichi

Tel

06-6972-1181

Email

mitui-ku@mc.pref.osaka.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

2010 Year 05 Month 17 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

Open public recruiting

Date of protocol fixation

2010 Year 03 Month 29 Day

Date of IRB


Anticipated trial start date

2010 Year 05 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

2010 Year 05 Month 17 Day

Last modified on

2020 Year 05 Month 25 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004390


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name