UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059956 |
|---|---|
| Receipt number | R000068579 |
| Scientific Title | Retrospective study of treatment outcomes and safety of preoperative chemotherapy for resectable esophageal cancer |
| Date of disclosure of the study information | 2025/12/10 |
| Last modified on | 2025/12/03 11:49:18 |
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Basic information
Public title
Retrospective study of treatment outcomes and safety of preoperative chemotherapy for resectable esophageal cancer
Acronym
Retrospective study of treatment outcomes and safety of preoperative chemotherapy for resectable esophageal cancer
Scientific Title
Retrospective study of treatment outcomes and safety of preoperative chemotherapy for resectable esophageal cancer
Scientific Title:Acronym
Retrospective study of treatment outcomes and safety of preoperative chemotherapy for resectable esophageal cancer
Region
| Japan |
Condition
Condition
Esophageal cancer
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Esophageal cancer is the sixth leading cause of cancer death worldwide, and the 5-year survival rate for advanced esophageal cancer is poor, at 15%. The standard neoadjuvant treatment for resectable advanced esophageal cancer has been 5-FU plus cisplatin (FP therapy). However, in 2024, it was reported that FP plus docetaxel (DCF therapy) significantly extended overall survival compared with FP therapy (4). This study aimed to evaluate the therapeutic outcomes and safety of FP therapy and DCF therapy as neoadjuvant standard treatments for resectable advanced esophageal cancer.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
disease free survival
Key secondary outcomes
response rate, overall survival, frequency of adverse event
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
resectable esophageal cancer patient
Key exclusion criteria
none
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Kohei |
| Middle name | |
| Last name | Nagata |
Organization
University of toyama
Division name
third department of internal medicine
Zip code
930-0192
Address
Sugitani2630 Toyama-city
TEL
076-434-7301
nagatako@med-u.toyama.ac.jp
Public contact
Name of contact person
| 1st name | Kohei |
| Middle name | |
| Last name | Nagata |
Organization
University of toyama
Division name
Third department of ineternal medicine
Zip code
930-0192
Address
Sugitani2630 Toyama-city
TEL
076-434-7301
Homepage URL
nagatako@med-u.toyama.ac.jp
Sponsor or person
Institute
University of toyama
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
University of toyama
Address
Sugitani2630 Toyama-city
Tel
076-434-7301
nagatako@med-u.toyama.ac.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 | 12 | Month | 10 | 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 | 11 | Month | 13 | Day |
Date of IRB
| 2025 | Year | 11 | Month | 26 | Day |
Anticipated trial start date
| 2025 | Year | 11 | Month | 26 | Day |
Last follow-up date
| 2027 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
none
Management information
Registered date
| 2025 | Year | 12 | Month | 03 | Day |
Last modified on
| 2025 | Year | 12 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068579
