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UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000028297
Receipt No. R000032243
Scientific Title A non-randomized confirmatory trial for the usefulness of endoscopic ultrasonography for diagnosing cancer invasion depth of clinical stage IA esophageal squamous cell carcinoma (JCOG1604, Odyssey trial)
Date of disclosure of the study information 2017/07/20
Last modified on 2017/07/20

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Basic information
Public title A non-randomized confirmatory trial for the usefulness of endoscopic ultrasonography for diagnosing cancer invasion depth of clinical stage IA esophageal squamous cell carcinoma (JCOG1604, Odyssey trial)
Acronym A non-randomized confirmatory trial for the usefulness of endoscopic ultrasonography for diagnosing cancer invasion depth of clinical stage IA esophageal squamous cell carcinoma (JCOG1604, Odyssey trial)
Scientific Title A non-randomized confirmatory trial for the usefulness of endoscopic ultrasonography for diagnosing cancer invasion depth of clinical stage IA esophageal squamous cell carcinoma (JCOG1604, Odyssey trial)
Scientific Title:Acronym A non-randomized confirmatory trial for the usefulness of endoscopic ultrasonography for diagnosing cancer invasion depth of clinical stage IA esophageal squamous cell carcinoma (JCOG1604, Odyssey trial)
Region
Japan

Condition
Condition clinical stage IA esphageal cancer
Classification by specialty
Gastroenterology Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The objective of this study is to confirm superiority of conventional and magnifying endoscopy followed by endoscopic ultrasonography (EUS) over conventional and magnifying endoscopy in terms of diagnostic accuracy for patients with clinical T1[MM or SM]N0M0 esophageal cancer.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Phase III

Assessment
Primary outcomes The proportion of pathological SM1 or shallower lesions in those with a diagnosis of clinical SM2 or deeper.
Key secondary outcomes The proportion of pathological SM2 or deeper lesions in those with a diagnosis of clinical SM1 or shallower, sensitivity, specificity, positive predictive value, negative predictive value, adverse events

Base
Study type Interventional

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

Intervention
No. of arms 1
Purpose of intervention Diagnosis
Type of intervention
Device,equipment
Interventions/Control_1 Conventional and magnifying endoscopy, Endoscopic ultrasonography (EUS)
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
85 years-old >=
Gender Male and Female
Key inclusion criteria 1st registration
1. Histologically proven squamous cell carcinoma or diagnosed as esophageal cancer (EC) by endoscopy according to Japanese Classification of Esophageal Cancer, 11th Edition. Also eligible in histologically proven high grade intraepithelial neoplasia according to 10th Edition
2. cN0M0 if CT examination is performed. Also eligible without imaging examination
3. Primary tumor is located in the thoracic esophagus
4. Depth of invasion of the deepest tumor is diagnosed as cT1 EC by conventional endoscopy. But ineligible when evidently diagnosed as cEP or cLPM
5. Length of the lesion is estimated <= 5 cm in longitudinal axis
6. Aged 20 to 85 years old
7. ECOG PS of 0-2
8. No evident entire circumferential lesion for patients with PS 2 and/or aged >= 81 years old
9. Magnifying endoscopy or EUS is judged to pass through by the endoscopic examination before 1st registration. Endoscopic dilation is allowed to pass through the magnifying endoscopy or EUS
10. No prior history of thoracic radiotherapy for any cancers
11. No prior history of esophagectomy for EC
12. Prior history of ER for EC is allowed. Ineligible if the scar after ER is located within <= 10 mm from the lesion
13. No preference of chemoradiotherapy or radiotherapy for primary treatment
14. Written informed consent
2nd registration
1. cN0M0 if examination is performed by CT before 2nd registration. Also eligible without imaging examination at 2nd registration
2. Depth of invasion is diagnosed as cMM or cSM by conventional and magnifying endoscopy
3. The upper end of the tumor is located at >= 2 cm from esophageal orifice, and the lower end of the tumor is located at >= 1 cm from esophagogastric junction
4. Length of the lesion is <= 5 cm in longitudinal axis
5. No entire circumferential lesion for patients with PS 2 and/or aged >= 81 years old
6. The scar after ER is located >= 10 mm from the lesion if the patient has prior history of ER
Key exclusion criteria 1. Active infection requiring systemic therapy
2. Body temperature >= 38 degrees Celsius
3. Pregnancy, possible pregnancy within 28 days after delivery or breastfeeding
4. Severe psychiatric disease
5. Poorly controlled hypertension
6. Unstable angina within 3 weeks, or with a history of myocardial infarction within 6 months
Target sample size 360

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Manabu Muto
Organization Graduate School of Medicine, Kyoto University
Division name Department of Therapeutic Oncology
Zip code
Address 54 Kawaharacho, Shogoin, Sakyo, Kyoto, 606-8507, Japan
TEL 075-751-4592
Email mmuto@kuhp.kyoto-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Ryu Ishihara
Organization JCOG1604 Coordinating Office
Division name Gastrointestinal Oncology Division, Osaka International Cancer Institute
Zip code
Address 3-1-69, Otemae, Chuo-ku, Osaka, Osaka prefecture, 541-8567, Japan
TEL 06-6945-1181
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 北海道大学病院(北海道)
岩手県立中央病院(岩手県)
山形県立中央病院(山形県)
福島県立医科大学附属病院(福島県)
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)
慶應義塾大学病院(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)
NTT東日本関東病院(東京都)
神奈川県立病院機構神奈川県立がんセンター(神奈川県)
横浜市立市民病院(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)
新潟大学医歯学総合病院(新潟県)
富山県立中央病院(富山県)
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)
愛知県がんセンター愛知病院(愛知県)
京都大学医学部附属病院(京都府)
大阪国際がんセンター(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)
兵庫医科大学(兵庫県)
兵庫県立がんセンター(兵庫県)
広島大学病院(広島県)
広島市立広島市民病院(広島県)
広島市立安佐市民病院(広島県)
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
2017 Year 07 Month 20 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
2017 Year 05 Month 16 Day
Date of IRB
Anticipated trial start date
2017 Year 07 Month 20 Day
Last follow-up date
2022 Year 01 Month 20 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 07 Month 20 Day
Last modified on
2017 Year 07 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032243

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
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