UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054427 |
|---|---|
| Receipt number | R000062165 |
| Scientific Title | Impact of lymphatic and venous invasion patterns on postoperative prognosis and distant metastasis in esophageal squamous cell carcinoma following preoperative chemotherapy |
| Date of disclosure of the study information | 2024/12/01 |
| Last modified on | 2024/05/18 14:56:23 |
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Basic information
Public title
Impact of lymphatic and venous invasion patterns on postoperative prognosis and distant metastasis in esophageal squamous cell carcinoma following preoperative chemotherapy
Acronym
Impact of lymphatic and venous invasion patterns on postoperative prognosis in ESCC after NAC
Scientific Title
Impact of lymphatic and venous invasion patterns on postoperative prognosis and distant metastasis in esophageal squamous cell carcinoma following preoperative chemotherapy
Scientific Title:Acronym
Impact of lymphatic and venous invasion patterns on postoperative prognosis in ESCC after NAC
Region
| Japan |
Condition
Condition
Esophageal squamous cell carcinoma
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
This study evaluates the postoperative prognosis and the postoperative distant metastatic recurrence pattern in patients who underwent radical esophagectomy after preoperative chemotherapy with different LVI patterns.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Overall survival (OS), Recurrence-free survival (RFS), Distant metastasis-free survival (DMFS)
Key secondary outcomes
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
| 18 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients with ESCC underwent subtotal esophagectomy with digestive tract reconstruction
Key exclusion criteria
1 Surgery alone
2 Neoadjuvant chemotherapy (NAC) regimen other than cisplatin and 5-fluorouracil (CF regimen) or docetaxel, cisplatin, and 5-fluorouracil (DCF regimen)
3 Preoperative chemoradiotherapy
4 R1 or R2 resection
5 unknown recurrence pattern
Target sample size
400
Research contact person
Name of lead principal investigator
| 1st name | Takeo |
| Middle name | |
| Last name | Fujita |
Organization
National Cancer Center Hospital East
Division name
Division of Esophageal Surgery
Zip code
277-8577
Address
6-5-1 Kashiwanoha, Kashiwa, Chiba, 277-8577, Japan
TEL
04-71331-111
takfujit@east.ncc.go.jp
Public contact
Name of contact person
| 1st name | Takeo |
| Middle name | |
| Last name | Fujita |
Organization
National Cancer Center Hospital East
Division name
Division of Esophageal Surgery
Zip code
277-8577
Address
6-5-1 Kashiwanoha, Kashiwa, Chiba, 277-8577, Japan
TEL
04-71331-111
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 Hospital East
Address
6-5-1 Kashiwanoha, Kashiwa, Chiba, 277-8577, Japan
Tel
04-7130-7130
chikensupport@east.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
| 2024 | Year | 12 | 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
427
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
Completed
Date of protocol fixation
| 2024 | Year | 02 | Month | 01 | Day |
Date of IRB
| 2024 | Year | 03 | Month | 01 | Day |
Anticipated trial start date
| 2024 | Year | 05 | Month | 18 | Day |
Last follow-up date
| 2024 | Year | 05 | Month | 18 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The clinicopathological data were collected from the patients' medical records. We evaluated postoperative long-term prognosis including OS, RFS, and DMFS.
Management information
Registered date
| 2024 | Year | 05 | Month | 18 | Day |
Last modified on
| 2024 | Year | 05 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062165
