UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043213 |
|---|---|
| Receipt number | R000049320 |
| Scientific Title | a prospective trial of deep inspiration breath hold-intensity modulated radiotherapy for postoperative breast cancer |
| Date of disclosure of the study information | 2021/02/01 |
| Last modified on | 2024/02/05 10:18:29 |
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Basic information
Public title
a prospective trial of deep inspiration breath hold-intensity modulated radiotherapy for postoperative breast cancer
Acronym
a prospective trial of DIBH-IMRT for postoperative breast cancer
Scientific Title
a prospective trial of deep inspiration breath hold-intensity modulated radiotherapy for postoperative breast cancer
Scientific Title:Acronym
a prospective trial of DIBH-IMRT for postoperative breast cancer
Region
| Japan |
Condition
Condition
breast cancer
Classification by specialty
| Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
to evaluate the safety and effectiveness of deep inspiration breath hold-intensity modulated radiotherapy for left breast cancer
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
acute and subacute adverse effects
Key secondary outcomes
late adverse effects, reduction of dose-volume histogram in risk organ comparing with 3D-CRT
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
42.4Gy/16fractions by deep inspiration breath hold-IMRT
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
| 60 | years-old | > |
Gender
Female
Key inclusion criteria
1. postoperative left breast cancer
2. need postoperative radiotherapy
3. good performance status(ECOG PS0-1)
4. can breath hold more than 10 seconds
5. written informed consent
Key exclusion criteria
see left
Target sample size
25
Research contact person
Name of lead principal investigator
| 1st name | Keiichi |
| Middle name | |
| Last name | Jingu |
Organization
Tohoku University Hospital
Division name
Department of Radiation Oncology
Zip code
9808574
Address
1-1 Seiryou-chou, Aobaku
TEL
0227177312
kjingu-jr@rad.med.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Keiichi |
| Middle name | |
| Last name | Jingu |
Organization
Tohoku University Hospital
Division name
Department of Radiation Oncology
Zip code
9808574
Address
Sendai
TEL
0227177312
Homepage URL
kjingurad@yahoo.co.jp
Sponsor or person
Institute
Tohoku University Hospital
Institute
Department
Personal name
Funding Source
Organization
self
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
MHLW Certified Clinical Research Review Board, Tohoku University
Address
1-1 Seiryou-chou, Aobaku, Sendai
Tel
022-171-7000
ec@rinri.hosp.tohoku.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
東北大学病院（宮城県）
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 02 | Month | 01 | Day |
Related information
URL releasing protocol
https://pubmed.ncbi.nlm.nih.gov/38091980/
Publication of results
Published
Result
URL related to results and publications
https://pubmed.ncbi.nlm.nih.gov/38091980/
Number of participants that the trial has enrolled
25
Results
The evaluation of adverse events showed that three patients (12.0%) had Grade 2 radiation dermatitis. There was no other Grade 2 adverse event and there was no patient with an adverse event of Grade 3 or higher.
Results date posted
| 2024 | Year | 02 | Month | 05 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2024 | Year | 01 | Month | 19 | Day |
Baseline Characteristics
Patients' characteristics
Age Median 47years
Performance status 0/1=25/0
pStage 0/IA/IB/IIA/IIB=2/16/0/6/1
Histology IDC/DCIS/others=21/2/2
Pathological tumor size Median=13.5mm
Boost Irradiation Yes/no=16/9
Participant flow
Twenty-five Japanese women were enrolled between February 2021 and November 2022 in this study. All of the enrolled patients completed the planned radiotherapy without interruption. Follow-up for 6 months or longer was performed for all of the enrolled patient.
Adverse events
Three patients (12.0%) had Grade 2 radiation dermatitis. There was no other Grade 2 adverse event and there was no patient with an adverse event of Grade 3 or higher.
Outcome measures
Those results confirmed our hypothesis that the experimental treatment method is non-inferior compared with our historical results. There was no patient with locoregional recurrence or metastases.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2021 | Year | 01 | Month | 26 | Day |
Date of IRB
| 2021 | Year | 01 | Month | 26 | Day |
Anticipated trial start date
| 2021 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 01 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 02 | Month | 01 | Day |
Last modified on
| 2024 | Year | 02 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049320
