Unique ID issued by UMIN | UMIN000017886 |
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Receipt number | R000020725 |
Scientific Title | Phase II study of dynamic tumor tracking stereotactic body radiotherapy for liver cancer. |
Date of disclosure of the study information | 2015/07/01 |
Last modified on | 2023/12/07 15:31:25 |
Phase II study of dynamic tumor tracking stereotactic body radiotherapy for liver cancer.
Phase II study of dynamic tumor tracking stereotactic body radiotherapy for liver cancer.
Phase II study of dynamic tumor tracking stereotactic body radiotherapy for liver cancer.
Phase II study of dynamic tumor tracking stereotactic body radiotherapy for liver cancer.
Japan |
liver cancer
Radiology |
Malignancy
NO
To evaluate the safety and efficacy of the sterotactic body radiotherapy for liver cancer.
Safety,Efficacy
Confirmatory
Others
Phase II
2-year local control rate
overall survival rate, progression free survival rate, local progression free survival rate, adverse event, severe adverse event, treatment accuracy, dose-volume index.
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Other |
Radiotherapy
20 | years-old | <= |
Not applicable |
Male and Female
1)Clinically diagnosed primary or metastatic liver cancers less than 4, and with diameter between 1 to 5 cm.
2) No indication or refusal for surgical resection, radio frequency ablation.
4) ECOG Performance Status 0-2
5) The patients can raise their arms and keep supine position with about 30 minutes.
6) Respiratory movement is more than 10mm.
7) Written informed consent
1) History of radiation therapy to the site
2) Refractory pleural effusion or ascites
3) Esophageal varies with high risk of bleeding
4) Obviously active interstitial pneumonia or pulmonary fibrosis
5) Severe diabetes or collagen disease
6) Pregnant and lactating females
7) Severe mental disorder to participate in this study
8) Patients who are concluded to be inappropriate to participate in this study by their physicians
48
1st name | |
Middle name | |
Last name | Takashi Mizowaki |
Kyoto University
Department of Radiation Oncology and Image-applied Therapy, Graduate School of Medicine
54 Shogoin Kawahara-cho, Sakyo-ku, Kyoto
075-751-3762
mizo@kuhp.kyoto-u.ac.jp
1st name | |
Middle name | |
Last name | Yukinori Matsuo |
Kyoto University
Department of Radiation Oncology and Image-applied Therapy, Graduate School of Medicine
54 Shogoin Kawahara-cho, Sakyo-ku, Kyoto
075-751-3762
ymatsuo@kuhp.kyoto-u.ac.jp
Kyoto University
Japan Agency for Medical Research and Development
Japanese Governmental office
Japan
NO
神戸市立医療センター中央市民病院(兵庫県) Kobe City Medical Center General Hospital
がん・感染症センター都立駒込病院(東京都) Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital
京都桂病院(京都府) Kyoto Katsura Hospital
日本赤十字社和歌山医療センター(和歌山県)Japanese Red Cross Wakayama Medical Center
2015 | Year | 07 | Month | 01 | Day |
none
Published
https://www.sciencedirect.com/science/article/pii/S2405630823000162
48
The 2-year local control rate (LC) was 98.0 %
2023 | Year | 12 | Month | 07 | Day |
2023 | Year | 03 | Month | 01 | Day |
Between September 2015 and March 2019, 48 patients (48 lesions) with a median age of 74 years were enrolled from 4 centers. The male:female ratio was 35:14. Thirty-nine lesions were hepatocellular carcinoma and nine were metastatic liver cancer. The median tumor diameter was 17.5 mm.
Between September 2015 and March 2019, 129 patients with liver tumors were referred to the participating institutions for indications of SBRT. Among them, 48 patients who met the inclusion criteria were registered in this study.
No acute adverse events of Grade 3 or higher were observed; Grade 3 late adverse events were observed in 7 patients (14.5%); no treatment-related toxicities of Grade 4 or 5 were observed.
Primary Endpoint: 2-year local control (LC) 98.0%.
Secondary endpoints: 2-year overall survival (OS) 88.8%, 2-year progression-free survival (PFS) 55.1%; disease progression was observed in 33 patients (68.8%). Local recurrence occurred in 1 case (0.2%), new liver lesions outside the irradiated field occurred in 31 cases (64.6%), and distant metastasis occurred in 9 cases (18.8%) (including duplicates).
Adverse event rate: see above
Tracking accuracy: median 2.9 mm
Main results already published
2015 | Year | 06 | Month | 02 | Day |
2015 | Year | 07 | Month | 24 | Day |
2015 | Year | 07 | Month | 24 | Day |
2021 | Year | 03 | Month | 14 | Day |
2021 | Year | 03 | Month | 30 | Day |
2021 | Year | 03 | Month | 30 | Day |
2015 | Year | 06 | Month | 12 | Day |
2023 | Year | 12 | Month | 07 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020725
Research Plan | |
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Registered date | File name |
2019/06/15 | 肝臓追尾プロトコル_201808.pdf |
Research case data specifications | |
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Registered date | File name |
Research case data | |
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Registered date | File name |
2021/03/30 | AMED追尾多施設肝202103.xlsx |