UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000017886
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

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Basic information

Public title

Phase II study of dynamic tumor tracking stereotactic body radiotherapy for liver cancer.

Acronym

Phase II study of dynamic tumor tracking stereotactic body radiotherapy for liver cancer.

Scientific Title

Phase II study of dynamic tumor tracking stereotactic body radiotherapy for liver cancer.

Scientific Title:Acronym

Phase II study of dynamic tumor tracking stereotactic body radiotherapy for liver cancer.

Region

Japan


Condition

Condition

liver cancer

Classification by specialty

Radiology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the safety and efficacy of the sterotactic body radiotherapy for liver cancer.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Others

Developmental phase

Phase II


Assessment

Primary outcomes

2-year local control rate

Key secondary outcomes

overall survival rate, progression free survival rate, local progression free survival rate, adverse event, severe adverse event, treatment accuracy, dose-volume index.


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Other

Interventions/Control_1

Radiotherapy

Interventions/Control_2


Interventions/Control_3


Interventions/Control_4


Interventions/Control_5


Interventions/Control_6


Interventions/Control_7


Interventions/Control_8


Interventions/Control_9


Interventions/Control_10



Eligibility

Age-lower limit

20 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

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

Key exclusion criteria

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

Target sample size

48


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Takashi Mizowaki

Organization

Kyoto University

Division name

Department of Radiation Oncology and Image-applied Therapy, Graduate School of Medicine

Zip code


Address

54 Shogoin Kawahara-cho, Sakyo-ku, Kyoto

TEL

075-751-3762

Email

mizo@kuhp.kyoto-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Yukinori Matsuo

Organization

Kyoto University

Division name

Department of Radiation Oncology and Image-applied Therapy, Graduate School of Medicine

Zip code


Address

54 Shogoin Kawahara-cho, Sakyo-ku, Kyoto

TEL

075-751-3762

Homepage URL


Email

ymatsuo@kuhp.kyoto-u.ac.jp


Sponsor or person

Institute

Kyoto University

Institute

Department

Personal name



Funding Source

Organization

Japan Agency for Medical Research and Development

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization

Japan


Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



Secondary IDs

Secondary IDs

NO

Study ID_1


Org. issuing International ID_1


Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions

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


Other administrative information

Date of disclosure of the study information

2015 Year 07 Month 01 Day


Related information

URL releasing protocol

none

Publication of results

Published


Result

URL related to results and publications

https://www.sciencedirect.com/science/article/pii/S2405630823000162

Number of participants that the trial has enrolled

48

Results

The 2-year local control rate (LC) was 98.0 %

Results date posted

2023 Year 12 Month 07 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results

2023 Year 03 Month 01 Day

Baseline Characteristics

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.

Participant flow

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.

Adverse events

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.

Outcome measures

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

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Main results already published

Date of protocol fixation

2015 Year 06 Month 02 Day

Date of IRB

2015 Year 07 Month 24 Day

Anticipated trial start date

2015 Year 07 Month 24 Day

Last follow-up date

2021 Year 03 Month 14 Day

Date of closure to data entry

2021 Year 03 Month 30 Day

Date trial data considered complete

2021 Year 03 Month 30 Day

Date analysis concluded



Other

Other related information



Management information

Registered date

2015 Year 06 Month 12 Day

Last modified on

2023 Year 12 Month 07 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020725


Research Plan
Registered date File name
2019/06/15 肝臓追尾プロトコル_201808.pdf

Research case data specifications
Registered date File name

Research case data
Registered date File name
2021/03/30 AMED追尾多施設肝202103.xlsx