UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038308 |
|---|---|
| Receipt number | R000043661 |
| Scientific Title | Accelerated Partial Breast Irradiation with Intensity Modulation Radiotherapy (MRT) after Breast Conservative Surgery |
| Date of disclosure of the study information | 2020/01/01 |
| Last modified on | 2020/04/16 11:21:52 |
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Basic information
Public title
Accelerated Partial Breast Irradiation with Intensity Modulation Radiotherapy (MRT) after Breast Conservative Surgery
Acronym
Accelerated Partial Breast Irradiation with IMRT
Scientific Title
Accelerated Partial Breast Irradiation with Intensity Modulation Radiotherapy (MRT) after Breast Conservative Surgery
Scientific Title:Acronym
Accelerated Partial Breast Irradiation with IMRT
Region
| Japan |
Condition
Condition
Breast Cancer
Classification by specialty
| Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The standard method of the radiation therapy in the breast conservative therapy is whole breast irradiation, but another method is Accelerated Partial Breast Irradiation (APBI) which irradiate to tumor bed during short treatment period.
It is an advantages of APBI that improvement of adverse reaction and decrease of the going to hospital number of times
We perform APBI clinical trial by Volumetric-modulated arc therapy (V-MAT), and it is thought that it is important to confirm safety, the effectiveness.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The rate of 2-year adverse events of grade 2 or worse
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Accelerated Partial Breast Irradiation (APBI)
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
| 40 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Female
Key inclusion criteria
1) Elderly patients aged between 50 and 80 years
2) Eastern Cooperative Oncology Group performance status
of 0 or 1
3) Pathological diameter of invasive or non invasive compon
ent =<2 cm
4) Invasive carcinoma or non invasive carcinoma
5) Single tumor
6) Positive estrogen receptor,
7) Distance between the surgical edge and cancer cell =>2
mm,
8) No axillary lymph node metastasis and
9) Written informed consent
Key exclusion criteria
Active second malignancy, uncontrolled infection, pregnanc
y, mental disorder, uncontrolled diabetes mellitus, interstitial
pneumonitis, collagen vascular diseases, heart failure and pr
evious history of radiofrequency ablation.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Jiro |
| Middle name | |
| Last name | Kawamori |
Organization
St Luke's International Hospital
Division name
Department of Radiation Oncology
Zip code
104-8560
Address
9-1 Akashucho Chuouku Tokyo
TEL
03-3541-5151
jirokawa@luke.ac.jp
Public contact
Name of contact person
| 1st name | Jiro |
| Middle name | |
| Last name | Kawamori |
Organization
St Luke's International Hospital
Division name
Department of Radiation Oncology
Zip code
104-8560
Address
9-1 Akashucho Chuouku Tokyo
TEL
03-3541-5151
Homepage URL
jirokawa@luke.ac.jp
Sponsor or person
Institute
St Luke's International Hospital
Institute
Department
Personal name
Funding Source
Organization
No
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
St Luke's International Hospital
Address
9-1 Akashucho Chuouku Tokyo
Tel
03-3541-5151
jirokawa@luke.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
| 2020 | Year | 01 | 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
| 2019 | Year | 12 | Month | 01 | Day |
Date of IRB
| 2019 | Year | 10 | Month | 30 | Day |
Anticipated trial start date
| 2019 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 10 | Month | 16 | Day |
Last modified on
| 2020 | Year | 04 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043661
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
