UMIN-CTR Clinical Trial

Basic information
Public title	Multicenter prospective study of stereotactic body radiotherapy for untreated solitary primary hepatocellular carcinoma
Acronym	Multicenter study of SBRT for untreated solitary HCC (STRSPH study)
Scientific Title	Multicenter prospective study of stereotactic body radiotherapy for untreated solitary primary hepatocellular carcinoma
Scientific Title:Acronym	Multicenter study of SBRT for untreated solitary HCC (STRSPH study)
Region	Japan

Condition
Condition	Untreated solitary primary hepatocellular carcinoma
Classification by specialty	Radiology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the efficacy of stereotactic body radiotherapy for untreated solitary primary hepatocellular carcinoma with liver cirrhosis of Child-Pugh score 7 or less in multi-institutional setting
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase	Phase II

Assessment
Primary outcomes	Three-year overall survival
Key secondary outcomes	Overall survival, three-year local control, local recurrence-free survival, three-year intrahepatic recurrence-free survival, three-year extrahepatic (lymph node and distant) metastasis-free survival, three-year proportion of death from hepatic failure, liver function at one and three year, treatment for the first recurrence, incidence of adverse event, incidence of serious adverse event

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	Stereotactic body 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	85 years-old >=
Gender	Male and Female
Key inclusion criteria	1)Histologically or clinically diagnosed untreated solitary primary hepatocellular carcinoma 2)Solitary hepatocellular carcinoma of 1- 5 cm (including vascular invasion) with typical radiological appearance (early enhancement and delayed washout on dynamic CT), without extrahepatic lesions, diagnosed within 60 days before registration during follow up of chronic hepatitis or cirrhosis (UICC 7th T1, T2, and a part of T3bN0M0) 3)Absence of previous local therapies (resection or percutaneous ablation) or transarterial chemoembolization, except for transarterial embolization (without chemotherapy) within 3 months 4)Pre-treatment liver function of Child- Pugh score 7 or less at registration 5)Aged 20-85 at registration 6)Unfit for resection or liver transplantation, or patient denial of these therapies 7)Unfit for percutaneous radiofrequency ablation or patient denial of the therapy 8)ECOG PS: 0-2 9)Met all requirements of dose constraints as defined on treatment planning 10)Well preserved major organ function fulfilling laboratory test limits as below a)White blood cell count: >3000/mm3 b)Platelet count: > 30000/mm3 c)Hemoglobin: > 8.0g/dl d)Total bilirubin: < 2.0mg/dl e)BUN: <35mg/dl f)Serum creatinine: <1.5mg/dl g)PT: >50% 11)Provision of informed consent from the patient
Key exclusion criteria	1)Ascites uncontrollable with medication 2)History of radiation therapy to the lesion of interest 3)Having esophageal varices which are at great risk of bleeding 4)Having active infectious diseases 5)Associated with other malignancies (simultaneous double cancer and heterochronic double cancer with disease-free time within 5 years), excluding carcinoma-in-situ or submucosal carcinoma treated with curative local therapies, glottis cancer staged as T1N0M0, low-risk prostate cancer (T1-2a, Gleason score 2-6 and PSA < 10 ng/ml), Stage I breast cancer, and other malignancies with comparatively favorable prognosis 6)Having interstitial pneumonitis, pulmonary fibrosis or severe respiratory disease such as pulmonary emphysema 7)Associated with mental illness or manifestation complicating study participation 8)Being pregnant or possible conception 9) Miscellaneous inappropriate conditions judged by physicians
Target sample size	60

Research contact person
Name of lead principal investigator	1st name Satoshi Middle name Last name Ishikura
Organization	Juntendo University
Division name	Department of Radiation Oncology
Zip code	113-842
Address	2-1-1 Hongo, Bunkyo-ku, Tokyo 113-8421, Japan
TEL	03-5802-1230
Email	s_ishiku@juntendo.ac.jp

Public contact
Name of contact person	1st name Tomoki Middle name Last name Kimura
Organization	Hiroshima University Hospital
Division name	Department of Radiation Oncology
Zip code	734-8551
Address	1-2-3 Kasumi, Minami-ku, Hiroshima-shi, Hiroshima 734-8551, Japan
TEL	082-257-1545
Homepage URL
Email	tkkimura@hiroshima-u.ac.jp

Sponsor
Institute	STRSPH study group
Institute
Department

Funding Source
Organization	Scientific Research from the Ministry of Education, Culture, Sports, Science and Technology of Japan
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Hiroshima University Hospital
Address	1-2-3 Kasumi, Minami-ku, Hiroshima-shi, Hiroshima 734-8551, Japan
Tel	082-257-5555
Email	hugcp@hiroshima-u.ac.jp

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	大船中央病院（神奈川県）、京都大学（京都府）、広島大学（広島県）、北海道大学（北海道）、国立がん研究センター中央（東京都）、名古屋西部医療センター（愛知県）、先端医療センター（兵庫県）、都立駒込病院（東京都）

Other administrative information
Date of disclosure of the study information	2014 Year 01 Month 30 Day

Related information
URL releasing protocol
Publication of results	Published

Result
URL related to results and publications
Number of participants that the trial has enrolled	36
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 11 Month 11 Day
Date of IRB	2014 Year 01 Month 24 Day
Anticipated trial start date	2014 Year 01 Month 30 Day
Last follow-up date	2020 Year 02 Month 28 Day
Date of closure to data entry	2020 Year 02 Month 28 Day
Date trial data considered complete	2020 Year 02 Month 28 Day
Date analysis concluded	2020 Year 04 Month 01 Day

Other
Other related information

Management information
Registered date	2014 Year 01 Month 30 Day
Last modified on	2021 Year 02 Month 05 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000014338