UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032003 |
|---|---|
| Receipt number | R000036526 |
| Scientific Title | Quality of Life and Dysphagia after Palliative RadiOtherapy for Malignant Esophageal Stenosis of esophageal carcinoma: Multi-institutional Cohort Observational Study |
| Date of disclosure of the study information | 2018/07/01 |
| Last modified on | 2024/08/26 09:06:18 |
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Basic information
Public title
Quality of Life and Dysphagia after Palliative RadiOtherapy for Malignant Esophageal Stenosis of esophageal carcinoma: Multi-institutional Cohort Observational Study
Acronym
Quality of Life and Dysphagia after Palliative RadiOtherapy for Malignant Esophageal Stenosis of esophageal carcinoma: Multi-institutional Cohort Observational Study
Scientific Title
Quality of Life and Dysphagia after Palliative RadiOtherapy for Malignant Esophageal Stenosis of esophageal carcinoma: Multi-institutional Cohort Observational Study
Scientific Title:Acronym
Quality of Life and Dysphagia after Palliative RadiOtherapy for Malignant Esophageal Stenosis of esophageal carcinoma: Multi-institutional Cohort Observational Study
Region
| Japan |
Condition
Condition
Esophageal cancer
Classification by specialty
| Gastroenterology | Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the dysphagia and quality of life after palliative radiotherapy for patients with malignant esophageal stenosis
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Improvement of dysphagia score 13 weeks after palliative radiotherapy
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Treated or untreated esophageal cancer
2) No indication for definitive treatment due to distant organ metastasis or poor general condition
3) 20 years old or higher
4) Dysphagia score with 1 or higher
5) Written informed consent
Key exclusion criteria
1) With a history of subtotal or total esophagectomy
2) Difficult to answer the EORTC QLQ-C30 and EORTC QLQ OES18
3) Less than 3 months of life expectancy
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Takashi |
| Middle name | |
| Last name | Mizowaki |
Organization
Kyoto university Graduate School of Medicine
Division name
Department of Radiation Oncology and Image-Applied Therapy
Zip code
6068507
Address
54 Sho-goinn, Kawaharacho, Sakyo-ku, Kyoto, Kyoto
TEL
075-751-3762
mizo@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Katsuyuki |
| Middle name | |
| Last name | Sakanaka |
Organization
Kyoto university Graduate School of Medicine
Division name
Department of Radiation Oncology and Image-Applied Therapy
Zip code
6068507
Address
54 Sho-goinn, Kawaharacho, Sakyo-ku, Kyoto, Kyoto
TEL
075-751-3762
Homepage URL
sakanaka@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto university
Institute
Department
Personal name
Funding Source
Organization
Japan Science and Technology Agency
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kyoto University Graduate School and Faculty of Medicine, Ethics Committee
Address
54 Sho-goinn, Kawaharacho, Sakyo-ku, Kyoto, Kyoto
Tel
075-753-4680
ethcom@kuhp.kyoto-u.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
| 2018 | Year | 07 | 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
95
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
Main results already published
Date of protocol fixation
| 2018 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2018 | Year | 06 | Month | 27 | Day |
Anticipated trial start date
| 2018 | Year | 12 | Month | 27 | Day |
Last follow-up date
| 2021 | Year | 12 | Month | 26 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study evaluate the dysphagia score, EORTC QLQ-C30 and EORTC QLQ-OES18 before palliative radiotherapy and 3, 6, 9, 12 months after palliative radiotherapy.
Management information
Registered date
| 2018 | Year | 03 | Month | 30 | Day |
Last modified on
| 2024 | Year | 08 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036526
