Unique ID issued by UMIN | UMIN000021237 |
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Receipt number | R000024499 |
Scientific Title | Brachytherapy using SAVI after breast-conserving surgery for breast cancer patients |
Date of disclosure of the study information | 2016/05/01 |
Last modified on | 2024/03/05 18:33:17 |
Brachytherapy using SAVI after breast-conserving surgery for breast cancer patients
SAVI study
Brachytherapy using SAVI after breast-conserving surgery for breast cancer patients
SAVI study
Japan |
Breast cancer
Breast surgery | Radiology | Adult |
Malignancy
NO
To evaluate the outcome of brachytherapy using SAVI.
Efficacy
Local control rate
Progression free survival rate
Overall survival rate
Complications
Cosmetic evaluation
Observational
40 | years-old | <= |
Not applicable |
Female
Primary registration
1) Tumor =<3 cm
2) cN0M0
3) Tumor is both unifocal and unicentric
4) Pathologically proven ductal, mucinous, tubular medullary, colloid, or lobular carcinoma
5) No prior history of breast cancer/ no bilateral breast cancer
6) No prior radiotherapy or chemotherapy for this breast cancer
7) Female and >40 years old
8) ECOG performance status 0-1
9) Informed consent was given
Secondary registration
1) Primary registration had been done
2) Breast conserving surgery was performed
3) Pathologically tumor <3 cm
4) Pathologically proven ductal, mucinous, tubular medullary, colloid, or lobular carcinoma after surgery
5) No extensive intraductal component
6) No lympho-vascular invasion
7) Surgical margin was not positive
8) pN0
9) Chemotherapy will be performed over 2 weeks later
Primary registration
1) Prior history of radiotherapy for chest
2) During pregnancy or lactating
3) Collagen disease
4) Psychiatric comorbidities
5) Prior invasive malignancy unless disease free for a minimum of 5 years
6) Uncontrolled diabetes mellitus
7) Attending physician believes the patient is not suitable for this study
Secondary registration
1) No conserving surgery
2) Paget disease
3) Unsuitable state for brachytherapy
4) Cosmetic evaluation is fair or poor before brachytherapy
5) Duration between surgery and brachytherapy was over 8 weeks
82
1st name | Jun |
Middle name | |
Last name | Itami |
Shin-Matsudo Central General Hospital
Radiation Therapy Center
270-0034
Shin-Matsudo 1-380, Matsudo-City, Chiba Pref.
047-345-1111
itami.jun@ims.gr.jp
1st name | Ryoichi |
Middle name | |
Last name | Yoshimura |
Tokyo Medical and Dental University Hospital
Department of Radiation Therapeutics and Oncology
113-8519
1-5-45 Yushima Bunkyo-ku Tokyo
03-5803-5311
ysmrmrad@tmd.ac.jp
Tokyo Medical and Dental University
Self funding
Self funding
Tokyo Medical and Dental University
1-5-45, Yushima, Bunkyo-ku, Tokyo
03-5803-5311
ysmrmrad@tmd.ac.jp
NO
2016 | Year | 05 | Month | 01 | Day |
Partially published
64
No longer recruiting
2016 | Year | 02 | Month | 28 | Day |
2016 | Year | 03 | Month | 18 | Day |
2016 | Year | 05 | Month | 01 | Day |
2026 | Year | 05 | Month | 31 | Day |
1.Brachytherapy
1)Planning
2)Complication
2. After brachytherapy
1) Outcome
Symptom/ US/ MMG
2) Complication
3. Cosmetic evaluation
2016 | Year | 02 | Month | 28 | Day |
2024 | Year | 03 | Month | 05 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024499
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