UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000553 |
|---|---|
| Receipt number | 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 15:22:09 |
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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
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/
JCOG_sir@ml.jcog.jp
Sponsor or person
Institute
Japan Clinical Oncology Group(JCOG)
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000653
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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