UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028297 |
|---|---|
| Receipt number | 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 | 2023/10/11 18:42:19 |
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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 | Manabu |
| Middle name | |
| Last name | Muto |
Organization
Graduate School of Medicine, Kyoto University
Division name
Department of Therapeutic Oncology
Zip code
606-8507
Address
54 Kawaharacho, Shogoin, Sakyo, Kyoto, 606-8507, Japan
TEL
075-751-4592
mmuto@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Ryu |
| Middle name | |
| Last name | Ishihara |
Organization
JCOG1604 Coordinating Office
Division name
Gastrointestinal Oncology Division, Osaka International Cancer Institute
Zip code
541-8567
Address
3-1-69, Otemae, Chuo-ku, Osaka, Osaka prefecture, 541-8567, Japan
TEL
06-6945-1181
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
National Cancer Center Institutional Review Board
Address
5-1-1 Tsukiji, Chuo-ku, Tokyo
Tel
03-3542-2511
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
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
This protocol is not open to the public.
Publication of results
Published
Result
URL related to results and publications
https://pubmed.ncbi.nlm.nih.gov/34524432/
Number of participants that the trial has enrolled
372
Results
See the datails via "URL related to results and publications" above.
Results date posted
| 2023 | Year | 10 | Month | 11 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Please refer to the "clinical study report (CSR)" posted on the following website.
https://jcog.jp/clinicaltrial/index.html
Participant flow
Please refer to the "clinical study report (CSR)" posted on the following website.
https://jcog.jp/clinicaltrial/index.html
Adverse events
Please refer to the "clinical study report (CSR)" posted on the following website.
https://jcog.jp/clinicaltrial/index.html
Outcome measures
Please refer to the "clinical study report (CSR)" posted on the following website.
https://jcog.jp/clinicaltrial/index.html
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2017 | Year | 05 | Month | 16 | Day |
Date of IRB
| 2017 | Year | 06 | Month | 29 | Day |
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
| 2020 | Year | 11 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 07 | Month | 20 | Day |
Last modified on
| 2023 | Year | 10 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032243
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| Registered date | File name |
| Research case data | |
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