UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061703 |
|---|---|
| Receipt number | R000070605 |
| Scientific Title | A Multicenter Prospective Observational Study on Surveillance After Non-Curative Endoscopic Resection for Esophageal Cancer |
| Date of disclosure of the study information | 2026/06/01 |
| Last modified on | 2026/05/27 12:36:57 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
A Multicenter Prospective Observational Study on Surveillance After Non-Curative Endoscopic Resection for Esophageal Cancer
Acronym
A Multicenter Prospective Observational Study on Surveillance After Non-Curative Endoscopic Resection for Esophageal Cancer
Scientific Title
A Multicenter Prospective Observational Study on Surveillance After Non-Curative Endoscopic Resection for Esophageal Cancer
Scientific Title:Acronym
A Multicenter Prospective Observational Study on Surveillance After Non-Curative Endoscopic Resection for Esophageal Cancer
Region
| Japan |
Condition
Condition
superficial esophageal cancer
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To clarify the outcomes of surveillance without additional treatment after non-curative endoscopic resection for esophageal cancer
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
3-year overall survival in the primary analysis population
Key secondary outcomes
5-year overall survival in the primary analysis population
Distant recurrence-free survival and esophagus-preservation survival at 3 and 5 years in the primary analysis population
Treatment for recurrent lesions and recurrence-free survival after recurrence treatment in patients with recurrence in the primary analysis population
Patterns of metastatic recurrence in the recommended surveillance cohort
Metastatic recurrence rates at 3 and 5 years in the overall study population
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Histologically confirmed squamous cell carcinoma or basaloid squamous cell carcinoma after endoscopic resection (ER) for esophageal cancer.
After ER for esophageal cancer, the primary lesion is pathologically diagnosed as pVM0 and either pMM with lymphovascular invasion or pSM. In patients with multiple lesions, the lesion with the deepest invasion is defined as the primary lesion.
En bloc resection has been achieved.
Within 60 days after ER of the primary lesion.
No additional treatment is planned after ER.
No evidence of lymph node metastasis or distant metastasis on cervical, thoracic, and abdominal CT performed within 90 days before ER or after ER for esophageal cancer.
No prior history of radiotherapy to the cervical region, thorax, lung fields, or mediastinum before the target ER, including radiotherapy for other malignancies.
No prior treatment history for esophageal cancer before the target ER. However, prior ER for esophageal cancer is permitted if the pathological findings were pT1a-EP/LPM with negative lymphovascular invasion and negative vertical margin.
Age >= 20 years at registration.
Patients must agree to undergo either of the following surveillance strategies:
a. Recommended surveillance
0-3 years after ER: contrast-enhanced CT of the neck, chest, and abdomen every 4 (3-5) months, and EGD (+EUS) at least once yearly
3-5 years after ER: contrast-enhanced CT of the neck, chest, and abdomen every 6 (4-8) months, and EGD (+EUS) at least once yearly
Non-contrast CT is permitted in patients unable to receive contrast agents because of renal dysfunction, contrast allergy, or other reasons.
b. Outpatient follow-up at least once yearly with CT examinations as clinically indicated.
Written informed consent for study participation has been obtained from the patient.
Key exclusion criteria
Presence of a prior or synchronous double cancer within the past 3 years; however, this does not include cancers with an estimated 5-year relative survival rate of >=95%.
Presence of psychiatric disorders or psychiatric symptoms that significantly interfere with activities of daily living and are judged to make study participation difficult.
Judged by the principal investigator or sub-investigator to be inappropriate for inclusion in the study.
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | Ryu |
| Middle name | |
| Last name | Ishihara |
Organization
Osaka International Cancer Institute
Division name
Department of Gastrointestinal Oncology
Zip code
541-8567
Address
1-69, Otemae 3-chome, Chuo-ku, Osaka, 541-8567, Japan
TEL
+81-6-6945-1181
ryu1486@gmail.com
Public contact
Name of contact person
| 1st name | Shunsuke |
| Middle name | |
| Last name | Yoshii |
Organization
Osaka International Cancer Institute
Division name
Department of Gastrointestinal Oncology
Zip code
541-8567
Address
1-69, Otemae 3-chome, Chuo-ku, Osaka, 541-8567, Japan
TEL
+81-6-6945-1181
Homepage URL
shunsuke.yoshii@oici.jp
Sponsor or person
Institute
Osaka International Cancer institute
Institute
Department
Personal name
Funding Source
Organization
NA
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Osaka International Cancer Institute Institutional Review Board
Address
1-69, Otemae 3-chome, Chuo-ku, Osaka, Japan
Tel
06-6945-1181
rinri01@opho.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
--- Select One ---
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 06 | Month | 01 | 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
| 2026 | Year | 05 | Month | 12 | Day |
Date of IRB
| 2026 | Year | 05 | Month | 12 | Day |
Anticipated trial start date
| 2026 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2033 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This is a multicenter prospective observational study evaluating the outcomes of surveillance without additional treatment after endoscopic resection in patients with esophageal cancer with pMM and lymphovascular invasion or pSM disease.
In routine clinical practice, patients who choose not to undergo additional treatment will be offered the recommended surveillance strategy, and their subsequent clinical outcomes will be evaluated.
Management information
Registered date
| 2026 | Year | 05 | Month | 27 | Day |
Last modified on
| 2026 | Year | 05 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070605
