UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013011 |
|---|---|
| Receipt number | R000014338 |
| Scientific Title | Multicenter prospective study of stereotactic body radiotherapy for untreated solitary primary hepatocellular carcinoma |
| Date of disclosure of the study information | 2014/01/30 |
| Last modified on | 2021/02/05 07:32:23 |
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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
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
tkkimura@hiroshima-u.ac.jp
Sponsor or person
Institute
STRSPH study group
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014338
