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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000000553
Receipt No. R000000653
Scientific Title Single-arm confirmatory study on efficacy of combined treatment of endoscopic mucosal resection and chemoradiotherapy for clinical stage I esophageal carcinoma (JCOG0508)
Date of disclosure of the study information 2006/12/21
Last modified on 2015/11/10

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Basic information
Public title Single-arm confirmatory study on efficacy of combined treatment of endoscopic mucosal resection and chemoradiotherapy for clinical stage I esophageal carcinoma (JCOG0508)
Acronym Single-arm confirmatory study on efficacy of combined treatment of endoscopic mucosal resection and chemoradiotherapy for clinical stage I esophageal carcinoma (JCOG0508)
Scientific Title Single-arm confirmatory study on efficacy of combined treatment of endoscopic mucosal resection and chemoradiotherapy for clinical stage I esophageal carcinoma (JCOG0508)
Scientific Title:Acronym Single-arm confirmatory study on efficacy of combined treatment of endoscopic mucosal resection and chemoradiotherapy for clinical stage I esophageal carcinoma (JCOG0508)
Region
Japan

Condition
Condition clinical stage I (SM1-2) esophageal cancer
Classification by specialty
Gastroenterology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the efficacy and safety of combined treatment of endoscopic mucosal resection (EMR) and chemoradiotherapy for clinical stage I esophageal cancer with submucosal invasion (SM1-2).
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Phase III

Assessment
Primary outcomes 3-year overall survival in 'pM1-3, vascular invasion positive and margin negative cases' or 'pSM1-2 and margin negative cases'
Key secondary outcomes 3-year overall survival in all registered cases, progression-free survival in all registered cases, overall survival in pM1-3 and margin negative cases, overall survival in pM1-3, vascular invasion positive and margin negative cases, adverse events of EMR, adverse events of chemoradiotherapy

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine Maneuver
Interventions/Control_1 A: Combined treatment of endoscopic mucosal resection (EMR) and chemoradiotherapy
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
75 years-old >=
Gender Male and Female
Key inclusion criteria 1) Histologically proven squamous cell carcinoma of the esophagus
2) All tumors are located within the thoracic esophagus
3) Depth of invasion of main tumor is evaluated as clinical SM1-2
4) Multiple intra-esophageal tumors are less or equal two lesions and all of them are M1-2
5) clinical N0/M0
6) Size of main tumor and circularity are less or equal 5cm and three fourth, respectively
7) No ulcerative lesion on tumors
8) No multiple unstained area with iodine except tumors
9) No intra-esophageal metastasis
10) No prior treatment of chemotherapy or radiation therapy against any other malignancies, and no prior treatment for esophageal cancer except EMR (M1-3 tumors)
11) Aged 20 to 75 years old
12) PS of 0 or 1
13) Sufficient organ functions
14) Written informed consent
Key exclusion criteria 1) Iodine allergy
2) Impossible to discontinue anticoagulant or antiplatelet medications
3) Simultaneous or metachronous (within 5 years) double cancers except intramucosal tumor curable with local therapy
4) Women during pregnancy or breast-feeding
5) Psychosis
6) Systemic steroids medication
7) HBs antigen positive
8) Active bacterial or fungous infection
9) History of myocardial infarction within three months or unstable angina pectoris
10) Uncontrollable hypertension
11) Uncontrollable diabetes millutus or administration of insulin
12) Interstitial pneumonia, fibroid lung or severe emphysema
Target sample size 82

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Manabu Muto
Organization Kyoto University Hospital
Division name Therapeutic Oncology
Zip code
Address 54 Kawaramachi, Shougoin, Kyoto 606-8507, JAPAN
TEL 075-751-4319
Email mmuto@kuhp.kyoto-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Keiko Minashi
Organization JCOG0508 Coordinating Office
Division name Chiba Cancer Center Hospital
Zip code
Address 666-2,Nitona-cho,Chuo-ku,Chiba,Chiba 260-8717,Japan
TEL 043-264-5431
Homepage URL http://www.jcog.jp/
Email JCOG_sir@ml.jcog.jp

Sponsor
Institute Japan Clinical Oncology Group(JCOG)
Institute
Department

Funding Source
Organization National Cancer Center
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization Japan

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 岩手医科大学(岩手県)
岩手県立中央病院(岩手県)
茨城県立中央病院・茨城県地域がんセンター(茨城県)
栃木県立がんセンター(栃木県)
国立がん研究センター東病院(千葉県)
千葉県がんセンター(千葉県)
国立がん研究センター中央病院(東京都)
昭和大学病院(東京都)
がん研究会有明病院(東京都)
虎の門病院(東京都)
神奈川県立がんセンター(神奈川県)
北里大学医学部(神奈川県)
横浜市立大学附属市民総合医療センター(神奈川県)
石川県立中央病院(石川県)
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)
愛知県がんセンター中央病院(愛知県)
京都大学医学部附属病院(京都府)
大阪府立病院機構大阪府立成人病センター(大阪府)
大阪市立総合医療センター(大阪府)
大阪医科大学(大阪府)
神戸大学医学部(兵庫県)
兵庫県立がんセンター(兵庫県)
国立病院機構四国がんセンター(愛媛県)
高知医療センター(高知県)

Other administrative information
Date of disclosure of the study information
2006 Year 12 Month 21 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 No longer recruiting
Date of protocol fixation
2006 Year 10 Month 25 Day
Date of IRB
Anticipated trial start date
2006 Year 12 Month 21 Day
Last follow-up date
2017 Year 12 Month 21 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2006 Year 12 Month 21 Day
Last modified on
2015 Year 11 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000653

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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