UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052644 |
|---|---|
| Receipt number | R000060045 |
| Scientific Title | Multicenter research survey of radical radiotherapy for endometiral cancer and Analysis of appropriate dosimetry The Gynecological Oncology group of Japanese Radiation Oncology Study Group |
| Date of disclosure of the study information | 2023/11/01 |
| Last modified on | 2023/11/01 08:48:28 |
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Basic information
Public title
Multicenter research survey of radical radiotherapy for endometiral cancer and Analysis of appropriate dosimetry
The Gynecological Oncology group of Japanese Radiation Oncology Study Group
Acronym
Multicenter research survey of radical radiotherapy for endometiral cancer and Analysis of appropriate dosimetry
Scientific Title
Multicenter research survey of radical radiotherapy for endometiral cancer and Analysis of appropriate dosimetry
The Gynecological Oncology group of Japanese Radiation Oncology Study Group
Scientific Title:Acronym
Multicenter research survey of radical radiotherapy for endometiral cancer and Analysis of appropriate dosimetry
Region
| Japan |
Condition
Condition
Endometrial cancer
Classification by specialty
| Obstetrics and Gynecology | Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate the actual situation of radical radiotherapy for endometrial cancer in Japan, to study the problems involved, and to establish a dosimetry method. Ultimately, the aim is to establish basic data for consensus-building on image-guided Brachytherapy for endometrial cancer.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Overall survival rate
Key secondary outcomes
Local control rate, pelvic control rate, recurrence-free survival rate, distant regression-free survival rate, rectal late adverse events, bladder late adverse events,Dosimetry.
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
Female
Key inclusion criteria
(a) Histopathologically confirmed to be endometrial cancer (adenocarcinoma, adenosquamous carcinoma), FIGO stage I-IVA.
(b) The patient has undergone radical treatment for uterine cancer between 1 January 2008 and 31 December 2017 at this hospital and at the respective performing institution.
(b) Patients who underwent radical radiotherapy (external-beam radiation combined with Brachytherapy or Brachytherapy alone) for endometrial cancer at this hospital or at the respective centre between 1 January 2008 and 31 December 2017 and were followed up for at least 2 years. However, cases who died within 2 years are included, as they may have died of cancer or accidental death within 2 years.
(c) Age is 20 years or older at the start of treatment.
(d) Cases were treated for the first time for endometrial cancer.
Key exclusion criteria
(a) patients who refused to register their data
(b) Patients who had external radiotherapy with particle radiotherapy.
(c) Patients with a history of pelvic irradiation.
(d) Patients with active overlapping cancers.
(e) Patients who have not received a curative dose as radiotherapy for endometrial cancer. Specifically, patients with pelvic doses of less than 30 Gy when combined with external irradiation and patients who have not undergone Brachytherapy should be excluded.
(f) Other cases deemed inappropriate by the physician in charge.
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | Yuko |
| Middle name | |
| Last name | Kaneyasu |
Organization
National Hospital Organisation Fukuyama Medical Centre
Division name
Department of Radiation Oncology
Zip code
7208520
Address
4-14-17 Okinoue-cho, Fukuyama, Hiroshima, Japan
TEL
084-922-0001
kaneyasuyuko@gmail.com
Public contact
Name of contact person
| 1st name | Yuko |
| Middle name | |
| Last name | Kaneyasu |
Organization
National Hospital Organisation Fukuyama Medical Centre
Division name
Department of Radiation Oncology
Zip code
7208520
Address
4-14-17 Okinoue-cho, Fukuyama, Hiroshima, Japan
TEL
084-922-0001
Homepage URL
kaneyasuyuko@gmail.com
Sponsor or person
Institute
National Hospital Organisation Fukuyama Medical Centre
Institute
Department
Personal name
Kazutoshi Murata
Funding Source
Organization
Japan mHDR Research Society
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 Institutes for Quantum Science and Technology Certified Review Board
Address
4-9-1 Anagawa, Inage-ku, Chiba City
Tel
043-206-4706
helsinki@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
国立病院機構福山医療センター放射線治療科、新潟県立がんセンター放射線科、自治医科大学付属病院放射線科、群馬大学医学部附属病院放射線科、群馬県立がんセンター放射線科、筑波大学附属病院放射線腫瘍科、東京都立駒込病院放射線診療科(治療部)、埼玉医科大学国際医療センター放射線腫瘍科、埼玉県立がんセンター放射線治療科、千葉大学医学部附属病院放射線科、量子科学技術研究開発機構 QST 病院、国立がん研究センター放射線治療科、順天堂大学放射線科、神奈川県立がんセンター放射線治療科、伊勢赤十字病院放射線治療科、大阪大学放射線治療科、琉球大学放射線科
Other administrative information
Date of disclosure of the study information
| 2023 | 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
Enrolling by invitation
Date of protocol fixation
| 2022 | Year | 07 | Month | 22 | Day |
Date of IRB
| 2023 | Year | 06 | Month | 15 | Day |
Anticipated trial start date
| 2023 | 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
Currently collecting data.
Management information
Registered date
| 2023 | Year | 10 | Month | 30 | Day |
Last modified on
| 2023 | Year | 11 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060045
