UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057425 |
|---|---|
| Receipt number | R000065598 |
| Scientific Title | Evaluation of the Superiority of Robot-Assisted Esophagectomy Over Thoracoscopic Esophagectomy for Locally Advanced Esophageal Cancer |
| Date of disclosure of the study information | 2025/03/28 |
| Last modified on | 2026/03/28 20:47:13 |
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Basic information
Public title
Evaluation of the Superiority of Robot-Assisted Esophagectomy Over Thoracoscopic Esophagectomy for Locally Advanced Esophageal Cancer
Acronym
Evaluation of the Superiority of Robot Surgery Over Thoracoscopic Surgery for Locally Advanced Esophageal Cancer
Scientific Title
Evaluation of the Superiority of Robot-Assisted Esophagectomy Over Thoracoscopic Esophagectomy for Locally Advanced Esophageal Cancer
Scientific Title:Acronym
Evaluation of the Superiority of Robot Surgery Over Thoracoscopic Surgery for Locally Advanced Esophageal Cancer
Region
| Japan |
Condition
Condition
Esophageal cancer
Classification by specialty
| Surgery in general | Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To demonstrate that robot-assisted esophagectomy is superior to thoracoscopic esophagectomy for locally advanced esophageal cancer.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Superiority of the 3-year recurrence-free survival rate
Key secondary outcomes
3-year overall survival rate, rate of curative resection, rate of reoperation, conversion rate, complication rate, recurrent laryngeal nerve palsy rate, respiratory complication rate, postoperative surgical invasiveness (postoperative CRP), number of upper mediastinal lymph node dissections, local control rate (presence or absence of local recurrence), 3-year recurrence-free survival rate by TNM stage
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) The esophageal primary lesion has been diagnosed histologically as either adenocarcinoma, squamous cell carcinoma, adenosquamous carcinoma, or basaloid carcinoma based on endoscopic biopsy.
2) The primary esophageal lesion must be located within the thoracic esophagus, as defined by the UICC TNM-8th edition. However, cases in which the tumor center is located distal to a line 1 cm oral to the esophagogastric junction-identified endoscopically as either the lower edge of the palisade vessels or the upper margin of the gastric-folds are excluded, as these correspond to Siewert type II/III tumors.
3) The esophageal lesions may be single or multiple. Secondary lesions in the cervical esophagus are eligible if endoscopic treatment (EMR/ESD) is applicable, even if present.
4) The clinical stage is II (T3N0M0), III, or IVA, or IVB with M1a (supraclavicular lymph node metastasis) according to the JES classification, based on UICC TNM 8th edition. However, if preoperative therapy is performed, the following conditions must be met:
The clinical stage before treatment is II (T3N0M0), III, or IVA, or IVB with M1a (supraclavicular lymph node metastasis) according to the JES classification.
The regimen is not limited.
No distant metastasis is observed after preoperative treatment.
5) The patient's age at the time of surgery is between 20 and 80 years.
6) The Performance Status (PS) is 0 or 1 according to the ECOG criteria.
7) No prior treatment for esophageal cancer. However, the following treatment history is acceptable:
Endoscopic treatment (EMR/ESD) for the primary lesion was performed but did not result in curative resection (pT1a LPM or superficial with negative resection margins).
The patient has undergone preoperative chemotherapy.
Key exclusion criteria
The patient has active multiple cancers (synchronous or metachronous multiple cancers, with a disease-free interval of less than 5 years). However, carcinoma in situ or lesions equivalent to mucosal carcinoma, which are considered cured by local treatment, are not included as active multiple cancers.
The patient is undergoing continuous systemic administration of steroids or other immunosuppressive agents.
The patient has uncontrolled diabetes despite continuous use of insulin.
The patient has severe emphysema or pulmonary fibrosis as detected by pulmonary function tests or CT scans.
The patient has unstable angina (angina that has occurred or worsened within the past 3 weeks) or has a history of myocardial infarction within the past 6 months.
The patient has renal dysfunction (dialysis, creatinine 1.5), or severe liver dysfunction (total bilirubin >1.5, AST >100, ALT >100).
The patient who underwent salvage surgery after definitive chemoradiotherapy will be excluded.
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | Kazuhiro |
| Middle name | |
| Last name | Noma |
Organization
Okayama University Hospital
Division name
Department of Gastroenterological Surgery
Zip code
700-8558
Address
2-5-1 Shikata-cho, Kitaku, Okayama, Japan
TEL
086-235-7257
knoma@md.okayama-u.ac.jp
Public contact
Name of contact person
| 1st name | Takeo |
| Middle name | |
| Last name | Fujita |
Organization
National Cancer Center Hospital East
Division name
Department of Esophageal Surgery
Zip code
277-8577
Address
6-5-1 Kashiwanoha, Kashiwa-shi Chiba, Japan
TEL
04-7133-1111
Homepage URL
takfujit@east.ncc.go.jp
Sponsor or person
Institute
National Cancer Center Hospital East
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Cancer Center Research Ethics Review Committee
Address
6-5-1 Kashiwanoha, Kashiwa-shi Chiba, Japan
Tel
04-7133-1111
irst@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
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 03 | Month | 28 | 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
Preinitiation
Date of protocol fixation
| 2025 | Year | 03 | Month | 18 | Day |
Date of IRB
| 2024 | Year | 12 | Month | 23 | Day |
Anticipated trial start date
| 2025 | Year | 03 | Month | 29 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2025 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2026 | Year | 06 | Month | 01 | Day |
Date analysis concluded
Other
Other related information
We conducted a retrospective observational study analyzing eligible cases between January 2019 and December 2022. Case registration was performed from March 29 to December 31, 2025. Patient enrollment has been completed, and data cleaning is currently in progress, with statistical analyses planned thereafter.
Management information
Registered date
| 2025 | Year | 03 | Month | 27 | Day |
Last modified on
| 2026 | Year | 03 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000065598
