UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000049296 |
|---|---|
| Receipt number | R000056146 |
| Scientific Title | Analysis of multidisciplinary treatment using chemotherapy, carbon ion therapy, and surgery for stage II and III esophageal cancer |
| Date of disclosure of the study information | 2022/11/01 |
| Last modified on | 2023/11/10 08:23:52 |
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Basic information
Public title
Analysis of multidisciplinary treatment using chemotherapy, carbon ion therapy, and surgery for stage II and III esophageal cancer
Acronym
Analysis of multidisciplinary treatment using chemotherapy, carbon ion therapy, and surgery for stage II and III esophageal cancer
Scientific Title
Analysis of multidisciplinary treatment using chemotherapy, carbon ion therapy, and surgery for stage II and III esophageal cancer
Scientific Title:Acronym
Analysis of multidisciplinary treatment using chemotherapy, carbon ion therapy, and surgery for stage II and III esophageal cancer
Region
| Japan |
Condition
Condition
Stage II and III esophageal cancer
Classification by specialty
| Gastroenterology | Gastrointestinal surgery | Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate the usefulness and safety of multidisciplinary treatment of chemotherapy, carbon ion therapy, and surgery for stage II and III esophageal cancer.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Adverse reactions in normal tissues
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
| 20 | years-old | <= |
Age-upper limit
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1) Histologically confirmed thoracic esophageal squamous cell carcinoma.
(2) The clinical stage is II or III.
(3) Lesions for which therapeutic effects can be evaluated by endoscopy.
(4) Age is between 20 and 75 years old. Gender does not matter.
(5) PS (EROG) is 0 or 1.
(6) Radical treatment for esophageal cancer is possible.
(7) No history of treatment for esophageal cancer.
(8) The functions of major organs are maintained.
(9) Written informed consent has been obtained from the patient.
Key exclusion criteria
(1) Patients with a history of radiotherapy at the irradiation site.
(2) Active double cancer in other organs.
(3) Active interstitial pneumonia.
(4) Active and intractable infection in the planned irradiation area.
(5) HBs antigen, HCV antibody. HIV antibody and HTLV antibody positive.
(6) Cases judged inappropriate by the principal investigator
Target sample size
27
Research contact person
Name of lead principal investigator
| 1st name | Tetsuro |
| Middle name | |
| Last name | Isozaki |
Organization
National Institutes for Quantum Sciences and Technology QST Hospital
Division name
Department of radiology
Zip code
263-8555
Address
4-9-1, anagawa, inage-ku,chiba. japan
TEL
043-206-3306
isozaki.tetsuro@qst.go.jp
Public contact
Name of contact person
| 1st name | Tetsuro |
| Middle name | |
| Last name | Isozaki |
Organization
National Institutes for Quantum Sciences and Technology QST Hospital
Division name
Department of radiology
Zip code
263-8555
Address
4-9-1, anagawa, inage-ku,chiba. japan
TEL
043-206-3306
Homepage URL
isozaki.tetsuro@qst.go.jp
Sponsor or person
Institute
National Institutes for Quantum Sciences and Technology QST Hospital
Institute
Department
Personal name
Funding Source
Organization
National Institutes for Quantum Sciences and Technology QST Hospital
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Department of frontier surgery Graduate school of medicine, Chiba University
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Institutes for Quantum Sciences and Technology QST Hospital
Address
4-9-1, anagawa, inage-ku,chiba. japan
Tel
043-206-3306
isozaki.tetsuro@qst.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
| 2022 | Year | 11 | 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
Completed
Date of protocol fixation
| 2022 | Year | 11 | Month | 01 | Day |
Date of IRB
| 2022 | Year | 10 | Month | 13 | Day |
Anticipated trial start date
| 2022 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 11 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Data will be extracted from electronic medical records and other medical information processed in such a way that specific individuals cannot be identified unless the data is cross-checked with other information. Data from both Chiba University Hospital and QST Hospital will be shared for analysis.
Management information
Registered date
| 2022 | Year | 10 | Month | 24 | Day |
Last modified on
| 2023 | Year | 11 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000056146
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
