Unique ID issued by UMIN | UMIN000004184 |
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Receipt number | R000005028 |
Scientific Title | Prospective Study of Hypofractionated Partial Breast Irradiation using 3D-Conformal Radiotherapy |
Date of disclosure of the study information | 2010/09/13 |
Last modified on | 2016/12/26 14:25:02 |
Prospective Study of Hypofractionated Partial Breast Irradiation using 3D-Conformal Radiotherapy
3D-HPBI Trial
Prospective Study of Hypofractionated Partial Breast Irradiation using 3D-Conformal Radiotherapy
3D-HPBI Trial
Japan |
Breast cancer
Breast surgery | Radiology |
Malignancy
NO
To evaluate the safe and effectiveness of partial breast irradiation (30 Gy/5 fraction) for early breast cancer
Safety
Exploratory
Pragmatic
Phase II
2-year late adverse events
overall survival, disease-free survival, local recurrence-free survival, compliance for treatment, acute adverse events, cosmesis
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Maneuver |
Radiotherapy (Photon and/or electron)
30Gy/5fractions/2wks
50 | years-old | <= |
80 | years-old | >= |
Female
Stage 1
partial breast resection
axillary resection or sentinel lumph node biopsy were performed
invasive ductal carcinoma
less than 5.5 cm of the distance clip
PS0-1
no privious radiotherapy
informed consent
active double cancer
active infection
pregnancy
mental disorder
collagen disease
55
1st name | |
Middle name | |
Last name | Yoshikazu Kagami |
Showa University, School of Medicine
Radiation Oncology
Hatanodai 1-5-8, Hinagawa-ku, 142-8555 Tokyo Japan
03-6426-3228
kagami@med.showa-u.ac.jp
1st name | |
Middle name | |
Last name | Naoto Shikama |
Saitama Medical University International Hospital
Radiation Oncology
1397-1 Yamane Hidakashi, 350-1298, Japan
042-984-4111
nshikama0525@gmail.com
Health and Labor Sciences Research Grants (H21-018)
Health and Labor Sciences Research Grants (H21-018)
Other
NO
佐久総合病院(長野県)、埼玉医科大学国際医療センター(埼玉県)、聖路加国際病院(東京都)、都立駒込病院(東京都)
2010 | Year | 09 | Month | 13 | Day |
Published
https://www.ncbi.nlm.nih.gov/pubmed/27127160
Fifty-three patients were treated using photons in the supine position, and two patients received photon and electron beams. Three patients (5%) developed grade 2 symptomatic radiation pneumonitis at 5, 8, and 9 months after 3D-CRT APBI.
ILV10Gy should be lower than 10% to avoid symptomatic radiation pneumonitis after 3D-CRT APBI.
Completed
2010 | Year | 04 | Month | 01 | Day |
2010 | Year | 05 | Month | 01 | Day |
2015 | Year | 12 | Month | 31 | Day |
2015 | Year | 12 | Month | 31 | Day |
2016 | Year | 01 | Month | 01 | Day |
2016 | Year | 01 | Month | 10 | Day |
2010 | Year | 09 | Month | 10 | Day |
2016 | Year | 12 | Month | 26 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005028
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