UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000043763
Receipt number R000049960
Scientific Title Multi-institutional prospective observational study of post-treatment outcome for entire circumferential superficial esophageal cancer
Date of disclosure of the study information 2021/03/27
Last modified on 2023/03/28 16:18:18

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Basic information

Public title

Multi-institutional prospective observational study of post-treatment outcome for entire circumferential superficial esophageal cancer

Acronym

Outcome study for entire circumferential superficial esophageal cancer

Scientific Title

Multi-institutional prospective observational study of post-treatment outcome for entire circumferential superficial esophageal cancer

Scientific Title:Acronym

Outcome study for entire circumferential superficial esophageal cancer

Region

Japan


Condition

Condition

Esophageal cancer

Classification by specialty

Gastroenterology Gastrointestinal surgery Radiology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To clarify the clinical course (stenosis rate, prognosis, etc.) after of ESD, OPE, and CRT for entire circumferential superficial esophageal cancer, and explore the advantage and disadvantage of each initial treatment according to lesion's invasion depth and length.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Overall survival

Key secondary outcomes



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

20 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

1. Clinically diagnosed as esophageal squamous cell carcinoma
2. Lesions mainly located in the cervical, thoracic, and abdominal esophagus
3. The lesion's depth of invasion is clinically diagnosed as EP/LPM or MM/SM1
4. No lymph node metastasis and no distant metastasis (cN0M0)
5. The entire circumferential lesion or sub-circumferential lesion (only in the case that become or expected to become the entire circumferential mucosal defect after ESD)
6. All multiple lesions are clinically diagnosed as MM/SM1 and spreading to less than 3/4 circumference of esophageal wall
7. Plaaned to perform with ESD, OPE, CRT, or RT in two months, or already performed within two weeks
8. No prior treatment of radiation therapy to the cervical chest, lung, or mediastinum field for any malignancies
9. No prior treatment for esophageal cancer, except for complete resection by EMR/ESD (shaollower than pT1a-MM without lympovascular invasion) and fulfilling the following (1) and (2)
(1) The main lesion is located within 20 mm from the center of the scar after prior EMR/ESD
(2) The ordinally endoscopy (diameter of 9.6-10.4 mm) could not pass the esophagus deu to the scar after prior EMR/ESD
10. 20 years or older
11. Written informed consent

Key exclusion criteria

Synchronous or metachronous (within 1 year) malignancy

Target sample size

200


Research contact person

Name of lead principal investigator

1st name Tomonori
Middle name
Last name Yano

Organization

National Cancer Center Hospital East, Kashiwa, Chiba, Japan

Division name

Department of Gastroenterology and Endoscopy

Zip code

277-8577

Address

6-5-1, Kashiwanoha, Kashiwa, Chiba 277-8577, Japan

TEL

04-7133-1111

Email

toyano@east.ncc.go.jp


Public contact

Name of contact person

1st name Tomohiro
Middle name
Last name Kadota

Organization

National Cancer Center Hospital East, Kashiwa, Chiba, Japan

Division name

Department of Gastroenterology and Endoscopy

Zip code

277-8577

Address

6-5-1, Kashiwanoha, Kashiwa, Chiba 277-8577, Japan

TEL

04-7133-1111

Homepage URL


Email

tkadota@east.ncc.go.jp


Sponsor or person

Institute

National Cancer Center Hospital East, Kashiwa, Chiba, Japan

Institute

Department

Personal name



Funding Source

Organization

National Cancer Center Hospital East, Kashiwa, Chiba, Japan

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

NCC IRB office

Address

5-1-1, Tsukiji, Chuo-ku, Tokyo, Japan

Tel

03-3542-2511

Email

NCC_IRBoffice@ml.res.ncc.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

恵佑会第二病院(北海道)
東北大学病院(宮城県)
国立がん研究センター東病院(千葉県)
国立がん研究センター中央病院(東京都)
がん研究会有明病院(東京都)
虎の門病院(東京都)
がん・感染症センター都立駒込病院(東京都)
佐久総合病院佐久医療センター(長野県)
静岡県立静岡がんセンター(静岡県)
大阪市立大学医学部附属病院(大阪府)
大阪国際がんセンター(大阪府)
兵庫県立がんセンター(兵庫県)
岡山大学病院(岡山県)
広島大学病院(広島県)
福岡大学筑紫病院(福岡県)
長崎大学病院(長崎県)


Other administrative information

Date of disclosure of the study information

2021 Year 03 Month 27 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

2021 Year 03 Month 12 Day

Date of IRB

2021 Year 03 Month 17 Day

Anticipated trial start date

2021 Year 05 Month 24 Day

Last follow-up date

2029 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Study design: Observational study


Management information

Registered date

2021 Year 03 Month 27 Day

Last modified on

2023 Year 03 Month 28 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049960


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name