UMIN-CTR Clinical Trial

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

resectable hepatocellular carcinoma

Classification by specialty

Hepato-biliary-pancreatic medicine	Hepato-biliary-pancreatic surgery	Radiology

Classification by malignancy

Malignancy

Genomic information

YES

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

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)

Study type

Interventional

Basic design

Parallel

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Active

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

Japan Clinical Oncology Group (JCOG)

Institute

Department

Personal name

Organization

Japan Agency for Medical Research and Development

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Japan

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

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）

Date of disclosure of the study information

2017

Year

06

Month

19

Day

URL releasing protocol

Publication of results

Unpublished

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

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 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).

Registered date

2017

Year

06

Month

19

Day

Last modified on

2017

Year

06

Month

19

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031842