UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043568 |
|---|---|
| Receipt number | R000049756 |
| Scientific Title | The role of endoscopic resection in long-term results of chemoradiotherapy for T1bN0M0 thoracic esophageal squamous cell carcinoma |
| Date of disclosure of the study information | 2021/03/10 |
| Last modified on | 2022/02/09 08:48:06 |
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Basic information
Public title
The role of endoscopic resection in long-term results of chemoradiotherapy for T1bN0M0 thoracic esophageal squamous cell carcinoma
Acronym
The role of endoscopic resection in long-term results of chemoradiotherapy for T1bN0M0 thoracic esophageal squamous cell carcinoma
Scientific Title
The role of endoscopic resection in long-term results of chemoradiotherapy for T1bN0M0 thoracic esophageal squamous cell carcinoma
Scientific Title:Acronym
The role of endoscopic resection in long-term results of chemoradiotherapy for T1bN0M0 thoracic esophageal squamous cell carcinoma
Region
| Japan |
Condition
Condition
T1bN0M0 thoracic esophageal squamous cell carcinoma
Classification by specialty
| Gastroenterology | Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The purpose is to estimate the role of the endoscopic resection in long-term outcome of chemoradiotherapy for T1bN0M0 thoracic esophageal squamous cell carcinoma.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The results of 5-year local recurrence-free survival rate after chemoradiotherapy
Key secondary outcomes
The results of 5-year overall survival rate and 5-year organ conserving survival rate after chemoradiotherapy.
Acute and late 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
| 83 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients with T1bN0M0 TESCC treated with CRT at our institute from 2004 to 2017
Key exclusion criteria
Patients who do not meet the following criteria.
(1) younger than 83 years old, (2) histologically proven squamous cell carcinoma, (3) primary tumor site in the thoracic esophagus, (4)depth of tumor invasion was diagnosed clinically or pathologically T1b, (5) no clinical evidence of lymph node or distant metastasis, (6) no prior chemotherapy and/or radiotherapy for esophagus.
Target sample size
91
Research contact person
Name of lead principal investigator
| 1st name | Tomohiko |
| Middle name | |
| Last name | MIYAZAKI |
Organization
Keiyukai Sapporo Hospital
Division name
Department of Radiation Oncology
Zip code
003-0026
Address
1-1 minami, Hondori-9, Shiroishi-ku, Sapporo, Japan
TEL
0118632101
jamkina@hotmail.co.jp
Public contact
Name of contact person
| 1st name | Tomohiko |
| Middle name | Miyazaki |
| Last name | Miyazaki |
Organization
Keiyukai Sapporo Hospital
Division name
Department of Radiation Oncology
Zip code
003-0026
Address
1-1 minami, Hondori-9, Shiroishi-ku, Sapporo, Japan
TEL
0118632101
Homepage URL
jamkina@hotmail.co.jp
Sponsor or person
Institute
Keiyukai Sapporo Hospital
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
Keiyukai Sapporo Hospital
Address
1-1 minami, Hondori-9, Shiroishi-ku, Sapporo, Japan
Tel
0118632101
manabe@keiyukaisapporo.or.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
| 2021 | Year | 03 | Month | 10 | Day |
Related information
URL releasing protocol
https://ro-journal.biomedcentral.com/articles/10.1186/s13014-021-01972-6
Publication of results
Published
Result
URL related to results and publications
https://ro-journal.biomedcentral.com/articles/10.1186/s13014-021-01972-6
Number of participants that the trial has enrolled
91
Results
ER and tumor length were independent predictive factors for LRFS. Our study suggested that performance of ER prior to CRT improved the local control in patients with c/p T1bN0M0 ESCC. In addition, most of the patients who experienced local recurrence were treated with salvage ER, which contributed to preserving the organs.
Results date posted
| 2022 | Year | 02 | Month | 09 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Patients with c/p T1bN0M0 ESCC treated with CRT in our institution from 2004 to 2017.
Participant flow
We retrospectively reviewed the medical charts of 91 patients with c/p T1bN0M0 ESCC treated with CRT in our institution from 2004 to 2017.
Adverse events
Leukopenia was one of the most common acute AEs, and the incidence of grade 3 or higher leukopenia was 14.3% in our study. Other grade 3 or higher acute AEs included esophagitis (3.3%) and fever (1.1%). Grade 3 or higher late AEs included pleural effusion (1.1%) and pericardial effusion (1.1%). Grade 3 or higher pneumonitis was found in 4.4% of patients, and they were all treated with corticosteroids. One patient died from grade 5 radiation pneumonitis (RP) in this study.
Outcome measures
We calculated the overall survival rate, disease specific survival rate, and local recurrence free survival rate.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2004 | Year | 11 | Month | 25 | Day |
Date of IRB
| 2020 | Year | 11 | Month | 04 | Day |
Anticipated trial start date
| 2004 | Year | 11 | Month | 25 | Day |
Last follow-up date
| 2020 | Year | 11 | Month | 06 | Day |
Date of closure to data entry
Date trial data considered complete
| 2021 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2021 | Year | 04 | Month | 30 | Day |
Other
Other related information
Retrospective study of the long-term treatment results and adverse events of one institution, which is one of the high volume centers of esophageal surgery in Japan, and discussed about the positioning of CRT in radical treatment for cT1bN0M0 TESCC.
Management information
Registered date
| 2021 | Year | 03 | Month | 09 | Day |
Last modified on
| 2022 | Year | 02 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049756
