Unique ID issued by UMIN | UMIN000043213 |
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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 |
a prospective trial of deep inspiration breath hold-intensity modulated radiotherapy for postoperative breast cancer
a prospective trial of DIBH-IMRT for postoperative breast cancer
a prospective trial of deep inspiration breath hold-intensity modulated radiotherapy for postoperative breast cancer
a prospective trial of DIBH-IMRT for postoperative breast cancer
Japan |
breast cancer
Radiology |
Malignancy
NO
to evaluate the safety and effectiveness of deep inspiration breath hold-intensity modulated radiotherapy for left breast cancer
Safety,Efficacy
Phase II
acute and subacute adverse effects
late adverse effects, reduction of dose-volume histogram in risk organ comparing with 3D-CRT
Interventional
Single arm
Non-randomized
Open -no one is blinded
Historical
1
Treatment
Device,equipment |
42.4Gy/16fractions by deep inspiration breath hold-IMRT
20 | years-old | <= |
60 | years-old | > |
Female
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
see left
25
1st name | Keiichi |
Middle name | |
Last name | Jingu |
Tohoku University Hospital
Department of Radiation Oncology
9808574
1-1 Seiryou-chou, Aobaku
0227177312
kjingu-jr@rad.med.tohoku.ac.jp
1st name | Keiichi |
Middle name | |
Last name | Jingu |
Tohoku University Hospital
Department of Radiation Oncology
9808574
Sendai
0227177312
kjingurad@yahoo.co.jp
Tohoku University Hospital
self
Self funding
MHLW Certified Clinical Research Review Board, Tohoku University
1-1 Seiryou-chou, Aobaku, Sendai
022-171-7000
ec@rinri.hosp.tohoku.ac.jp
NO
東北大学病院(宮城県)
2021 | Year | 02 | Month | 01 | Day |
https://pubmed.ncbi.nlm.nih.gov/38091980/
Published
https://pubmed.ncbi.nlm.nih.gov/38091980/
25
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.
2024 | Year | 02 | Month | 05 | Day |
2024 | Year | 01 | Month | 19 | Day |
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
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.
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.
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.
Completed
2021 | Year | 01 | Month | 26 | Day |
2021 | Year | 01 | Month | 26 | Day |
2021 | Year | 02 | Month | 01 | Day |
2023 | Year | 01 | Month | 31 | Day |
2021 | Year | 02 | Month | 01 | Day |
2024 | Year | 02 | Month | 05 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049320
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