Unique ID issued by UMIN | UMIN000018240 |
---|---|
Receipt number | R000021088 |
Scientific Title | A clinical study on the safety of Hypofractionated Whole Breast Irradiation with Concurrent Boost in Breast conserving therapy |
Date of disclosure of the study information | 2015/07/10 |
Last modified on | 2020/03/02 21:28:46 |
A clinical study on the safety of Hypofractionated Whole Breast Irradiation with Concurrent Boost in Breast conserving therapy
A clinical study on the safety of Hypofractionated Whole Breast Irradiation with Concurrent Boost
A clinical study on the safety of Hypofractionated Whole Breast Irradiation with Concurrent Boost in Breast conserving therapy
A clinical study on the safety of Hypofractionated Whole Breast Irradiation with Concurrent Boost
Japan |
Breast Cancer
Breast surgery | Radiology |
Malignancy
NO
To evaluate safety of hypofractionated whole breast irradiation with concurrent boost in breast conserving treatment.
Safety
proportion of acute adverse events
proportion of late adverse events, proportion of deterioration of breast cosmetic outcomes
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Device,equipment | Maneuver |
Hypofractionated whole breast irradiation therapy (43.2Gy/18fr) with concurrent boost (50.4Gy/18fr) after breast conserving surgery
20 | years-old | <= |
Not applicable |
Female
Patients must fulfill all of the following conditions
1) clinical stage I, II
2) pathologically proven diagnosis of invasive ductal carcinoma, or specific type of carcinoma
3) positive resection margin or close resection margin within 5mm
4) Aged 20 years old or more
5) breast conserving surgery
6) inserted surgical clips in tumor resection margin or mark indicating the resection margin on the skin
7) whole breast irradiation without regional (supraclavicular or parasternal) nodal irradiation planned
8) no prior radiation therapy to thoracic
9) performance status (ECOG) of 0 or 1
10) written informed consent
11) oriental women with enough fluency in Japanese
1) Prior invasive non-breast malignancy (except carcinoma in situ) unless disease free for a minimum of 5 years prior to study entry
2) Metachronous or simultaneous bilateral breast cancers
3) Acute infection requiring systemic therapy
4) Body temperature 38 degrees Celsius or more at registration
5) Psychiatric or other condition that would prevent the patient from receiving the protocol therapy
6) Uncontrollable diabetes mellitus or administration of insulin
7) Active or prior history of scleroderma, systemic lupus erythematosus, dermatomyositis, or polymyositis
8) Systemic steroids or immunosuppressant medication
9) Severe heart failure or angina attack or myocardial infarction within the last 6 months
10) Interstitial pneumonia, pulmonary fibrosis, or severe chronic obstructive pulmonary disease
11) Pregnancy, pregnancy potential, after giving birth within 28 days, or lactating
15
1st name | |
Middle name | |
Last name | Masahiro Hiraoka |
Graduate school of Medicine, Kyoto University
Department of Radiation Oncology and Image-applied Therapy
54 Shogoin Kawaharacho Sakyo-ku, Kyoto
0753667654
hiraok@kuhp.kyoto-u.ac.jp
1st name | |
Middle name | |
Last name | Michio Yoshimura |
Graduate school of Medicine, Kyoto University
Department of Radiation Oncology and Image-applied Therapy
54 Shogoin Kawaharacho Sakyo-ku, Kyoto
0753667654
myossy@kuhp.kyoto-u.ac.jp
Department of Radiation Oncology and Image-applied Therapy, Graduate School of Medicine, Kyoto University
Kyoto University Hospital
Other
NO
京都大学医学部附属病院(京都府)
2015 | Year | 07 | Month | 10 | Day |
Unpublished
No longer recruiting
2015 | Year | 09 | Month | 01 | Day |
2015 | Year | 09 | Month | 24 | Day |
2015 | Year | 10 | Month | 01 | Day |
2020 | Year | 09 | Month | 24 | Day |
2015 | Year | 07 | Month | 07 | Day |
2020 | Year | 03 | Month | 02 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021088