UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000027811
Receipt No. R000031842
Scientific Title Non-randomized controlled study comparing proton beam therapy and hepatectomy for resectable hepatocellular carcinoma(JCOG1315C, SPRING study)
Date of disclosure of the study information 2017/06/19
Last modified on 2017/06/19

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Non-randomized controlled study comparing proton beam therapy and hepatectomy for resectable hepatocellular carcinoma(JCOG1315C, SPRING study)
Acronym Non-randomized controlled study comparing proton beam therapy and hepatectomy for resectable hepatocellular carcinoma(JCOG1315C, SPRING study)
Scientific Title Non-randomized controlled study comparing proton beam therapy and hepatectomy for resectable hepatocellular carcinoma(JCOG1315C, SPRING study)
Scientific Title:Acronym Non-randomized controlled study comparing proton beam therapy and hepatectomy for resectable hepatocellular carcinoma(JCOG1315C, SPRING study)
Region
Japan

Condition
Condition resectable hepatocellular carcinoma
Classification by specialty
Hepato-biliary-pancreatic medicine Hepato-biliary-pancreatic surgery Radiology
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 To confirm the non-inferiority of proton beam therapy compared with hepatectomy for resectable hepatocellular carcinoma
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Phase III

Assessment
Primary outcomes overall survival
Key secondary outcomes progression-free survival, patterns of failure, adverse events, acute non-hematological toxicities of Grade 3 or higher, late adverse reactions of Grade 3 or higher , serious adverse events, Child-Pugh score at 1, 3, and 5 years after the treatment, medical cost, quality of life (QOL), quality adjusted life years (QALY), incremental cost-effectiveness ratio (ICER)

Base
Study type Interventional

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

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Device,equipment Maneuver
Interventions/Control_1 A: hepatectomy
Interventions/Control_2 B: proton beam therapy
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
79 years-old >=
Gender Male and Female
Key inclusion criteria 1) single nodular hepatocellular carcinoma confirmed by dynamic contrast-enhanced CT or MRI of the liver within 28 days
2) cN0M0 diagnosed by dynamic contrast-enhanced CT or MRI of the upper abdomen and X ray or CT of the chest within 28 days
3) new-onset hepatocellular carcinoma
4) the maximum tumor diameter is larger than 3 cm and smaller than 12 cm
5) the margin of the tumor is at least 2 cm or more apart from the gastrointestinal tract
6) no invasion to or tumor thrombosis in the portal vein, the contralateral branches of the portal vein, or the first branch of the portal vein
7) no invasion to or tumor thrombosis in the inferior vena cava, the first branch of the hepatic vein, right inferior hepatic vein, or short hepatic vein
8) no invasion to or tumor thrombosis in the common bile duct or the first branch of the bile duct.
9) completely resectable by left lobectomy, anterior/posterior/lateral segmentectomy, extended subsegmentectomy, subsegmentectomy, or partial resection judged by the qualified surgeon and the cancer board including physicians of hepatobiliary and pancreatic surgery, hepatobiliary and pancreatic medicine, radiation oncology, and diagnostic radiology
10) No previous treatment for HCC
11) No ascites or hepatic encephalopathy
12) Age 20-79 years old
13) ECOG performance status of 0 or 1
14) Adequate organ functions
i) White blood cell (WBC) >= 2,000/mm3
ii) Platelet >= 50,000/mm3
iii) Hemoglobin >= 8.0 g/dl
iv) Total bilirubin < 2.0 mg/dl
v) Serum albumin > 3.5 g/dl
vi) Serum creatinine <= 1.5 mg/dl
vii) Prothrombin activity > 70%
15) Written informed consent
Key exclusion criteria 1) synchronous or metachronous (within 5 years) malignancy except cancer with 5-year relative survival rate of 95% or more such as carcinoma in situ, intramucosal tumor, or early stage cancers.
2) active infection requiring systemic therapy
3) body temperature >= 38 degrees Celsius
4) female during pregnancy, within 28 days of postparturition, or during lactation
5) severe psychological disorder
6) receiving continuous systemic corticosteroid or immunosuppressant treatment
7) poorly controlled diabetes mellitus or receiving the routine administration of insulin
8) poorly controlled hypertension
9) unstable angina within 3 weeks, or with a history of myocardial infarction within 6 months
10) interstitial pneumonia, pulmonary fibrosis, or severe emphysema on chest CT
11) esophageal varices
Target sample size 290

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tetsuo Akimoto
Organization National Cancer Center Hospital East
Division name Division of radiation Oncology and Particle Therapy
Zip code
Address 6-5-1, Kashiwanoha, Kashiwa, Chiba, 277-8577 Japan
TEL 04-7133-1111
Email takimoto@east.ncc.go.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tetsuo Akimoto
Organization JCOG1315 Coordinating Office
Division name Division of radiation Oncology and Particle Therapy, National Cancer Center Hospital East
Zip code
Address 6-5-1, Kashiwanoha, Kashiwa, Chiba, 277-8577 Japan
TEL 04-7133-1111
Homepage URL http://www.jcog.jp/
Email JCOG_sir@ml.jcog.jp

Sponsor
Institute Japan Clinical Oncology Group (JCOG)
Institute
Department

Funding Source
Organization Japan Agency for Medical Research and Development
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
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 北海道大学病院(北海道)
筑波大学医学医療系(茨城県)
自治医科大学(栃木県)
栃木県立がんセンター(栃木県)
埼玉県立がんセンター(埼玉県)
国立がん研究センター東病院(千葉県)
千葉県がんセンター(千葉県)
杏林大学医学部(東京都)
帝京大学医学部(東京都)
国立がん研究センター中央病院(東京都)
横浜市立大学附属市民総合医療センター(神奈川県)
神奈川県立病院機構神奈川県立がんセンター(神奈川県)
金沢大学医学部(石川県)
静岡県立静岡がんセンター(静岡県)
名古屋市立西部医療センター(愛知県)
大阪府立病院機構大阪府立成人病センター(大阪府)
関西医科大学附属枚方病院(大阪府)
国立病院機構大阪医療センター(大阪府)
神戸大学医学部(兵庫県)
国立病院機構九州がんセンター(福岡県)

Other administrative information
Date of disclosure of the study information
2017 Year 06 Month 19 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
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 Open public recruiting
Date of protocol fixation
2017 Year 05 Month 11 Day
Date of IRB
Anticipated trial start date
2017 Year 06 Month 19 Day
Last follow-up date
2029 Year 12 Month 19 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Advanced Medical Care B
Proton beam therapy is provided at National Cancer Center Hospital East (Chiba), Hokkaido University Hospital (Hokkaido), Faculty of Medicine University of Tsukuba (Ibaraki), Shizuoka Cancer Center (Shizuoka), and Nagoya City West Medical Center (Aichi). Among these five institutions, hepatectomy is also provided at National Cancer Center Hospital East (Chiba) and Shizuoka Cancer Center (Shizuoka).

Management information
Registered date
2017 Year 06 Month 19 Day
Last modified on
2017 Year 06 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031842

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.