Unique ID issued by UMIN | UMIN000017579 |
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Receipt number | R000020371 |
Scientific Title | A phase I/II study of proton beam therapy for early breast cancer evaluating safety and effectiveness |
Date of disclosure of the study information | 2015/05/15 |
Last modified on | 2023/05/23 16:48:06 |
A phase I/II study of proton beam therapy for early breast cancer evaluating safety and effectiveness
A phase I/II study of proton beam therapy for early breast cancer
A phase I/II study of proton beam therapy for early breast cancer evaluating safety and effectiveness
A phase I/II study of proton beam therapy for early breast cancer
Japan |
Breast cancer
Breast surgery | Radiology |
Malignancy
NO
To find optimal dose and to evaluate safety and effectiveness of proton beam therapy for stage I breast cancer
Safety,Efficacy
Confirmatory
Explanatory
Phase I,II
Adverse events of normal tissue
location of local recurrence, duration of extra-breast recurrence, survival duration, cosmesis
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Maneuver |
Proton beam therapy 62.4 GyE/26 fractions
40 | years-old | <= |
70 | years-old | >= |
Female
1) UICC-TNM classification stage I (equal or less than 1.5 cm in diameter) breast cancer.
2) Mammographicaly visible tumor without calcification.
3) Pathologically invasive ductal carcinoma.
4) No massive lymphovascular invasion.
5) Estrogen receptor positive, favor of HER2 negative.
6) Age 40-70 years old.
7) Hight </= 175 cm, body weight </= 70 kg.
8) Favor of distance to skin or rib >/= 1 cm.
9) Negative lymph node metastasis by sentinel lymph node sampling.
10) No distant metastasis.
11) Performance status 0-1.
12) Written informed consent.
13) Phase I is clinical trial.
14) Phase II is cost burden.
15) Salvage surgery will be required if recurrence is observed.
1) History of previous radiotherapy to the breast.
2) History of previous surgery/chemotherapy to the breast.
3) DCIS/LCIS
4) Massive intra-ductal spread.
5) Having infectious disease.
6) Having collagen disease or infectios skin disease.
7) Diabetes.
8) Pregnancy.
9) Other malignant disease.
10) Medically, psycholgicaliy or other reason who are not suitable for candidate by the physician.
24
1st name | Takashi |
Middle name | |
Last name | Ogino |
Medipolis Proton Therapy and Research Center
Proton Radiation Oncology Division
891-0304
4423 Higashikata, Ibusuki city, Kagoshima Prefecture, 891-0304 Japan
0993-23-5188
mptrc@medipolis.org
1st name | Takeshi |
Middle name | |
Last name | Arimura |
Medipolis Proton Therapy and Research Center
Proton Radiation Oncology Division
891-0304
4423 Higashikata, Ibusuki city, Kagoshima Prefecture, 891-0304 Japan
0993-23-5188
http://www.medipolis.org
mptrc-ask@medipolis.org
Medipolis Proton Therapy and Research Center
Medipolis Proton Therapy and Research Center
Self funding
Medipolis proton therapy and research center
4423 Higashikata Ibusuki Kagoshima
0993-23-5188
mptrc-ask@mediporis.org
NO
メディポリス国際陽子線治療センター
2015 | Year | 05 | Month | 15 | Day |
Unpublished
Open public recruiting
2015 | Year | 05 | Month | 11 | Day |
2015 | Year | 03 | Month | 20 | Day |
2015 | Year | 05 | Month | 15 | Day |
2031 | Year | 03 | Month | 31 | Day |
2015 | Year | 05 | Month | 15 | Day |
2023 | Year | 05 | Month | 23 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020371
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