UMIN-CTR Clinical Trial

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
Institute	Osaka Medical Center for Cancer and Cardiovascular Diseases
Institute
Department

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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000004390