UMIN-CTR Clinical Trial

Public title

Stereotactic radiotherapy(SRT) combined with transcatheter arterial chemoembolization(TACE) for hepatocellular carcinoma: Phase II trial

Acronym

SRT combined with TACE for HCC

Scientific Title

Stereotactic radiotherapy(SRT) combined with transcatheter arterial chemoembolization(TACE) for hepatocellular carcinoma: Phase II trial

Scientific Title:Acronym

SRT combined with TACE for HCC

Region

Japan

Condition

hepatocellular carcinoma

Classification by specialty

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

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

To evaluate efficacy and safty of stereotactic radiotherapy(SRT) combined with transcatheter arterial chemoembolization(TACE) for hepatocellular carcinoma( size less than or equall to 4cm):Phase II study

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Three year local pogression free survival

Key secondary outcomes

Three year overall survival
Median overall survival
Median overall progression free survival
Median local progression free survival
Median event free survival
Type of progression
Acute complication rate
Chronic complication rate
Severe complication rate

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Active

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Device,equipment

Maneuver

Interventions/Control_1

Stereotactic 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

Age-lower limit

20

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

The patients are diagnosed as hepatocellular carcinoma with the following criterion of A or B, and the other inclusion criterion are the following 1-9.

A.In patients with chronic HBV or HCV hepatitis, typical tumor appearances are needed in 3 phase enhanced CT or other dynamic images.
B.In patients without chronic HBV or HCV hepatitis, pathological diagnosis is needed in first HCC and typical tumor appearances are needed in 3 phase enhanced CT or other dynamic images during follow-up after treatment of first HCC.
1.Three phase enhanced CT or other dynamic images is performed within 28 days. And the tumor maximal diameter is less than or equal to 4 cm (includes recurrence after another treatment, macroscopic residual tumor after resection, RFA or PEIT).
2.Ablation therapy is difficult or unable to perform because the tumors exist in the area such as subphrenic area and vicinity of portal vein, or the tumor shape is too complicated.
3.Surgery is out of indication or is suspected to lead poor liver function after surgery.
4.Radiation doses at organ at risk do not exceed the criterion based on the imaging study perfomed within 28 days.
5.Child-Pugh classification A or B.
6.Age older than or equal to 20 years.
7.ECOG-PS: 0-2.
8.Written approvement is given from the candidate.

Key exclusion criteria

1.Active infectious disease needing treatment except for external application.
2.In or suspected pregnancy or breast-feeding
3.mental disease which prohibit the patients from understanding this trial.
4.successive steroid use ( oral or intra-venous administration).

Target sample size

100

Name of lead principal investigator

1st name
Middle name
Last name	Atsuya Takeda

Organization

Ofuna-Chuo Hospital

Division name

Department of Radiation Oncology

Zip code

Address

6-2-24 Ofuna, Kamakura, Kanagawa

TEL

0467-45-2111

Email

takeda@1994.jukuin.keio.ac.jp

Name of contact person

1st name
Middle name
Last name	Etsuo Kunieda

Organization

Fuculty of Medicine, Tokai Univ.

Division name

Department of Radiation Oncology

Zip code

Address

143 Shimokasuya Isehara, Kanagawa

TEL

0463-93-1121

Homepage URL

Email

kunieda@tokai-u.jp

Institute

Liver radiothrapy group

Institute

Department

Personal name

Organization

Liver radiothrapy group

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

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

Date of disclosure of the study information

2007

Year

04

Month

01

Day

URL releasing protocol

Publication of results

Published

URL related to results and publications

http://www.ncbi.nlm.nih.gov/pubmed/27062278

Number of participants that the trial has enrolled

Results

RESULTS: From 2007 to 2012, 101 patients were enrolled, and 90 were evaluable with a median follow-up of 41.7 months (range, 6.8-96.2 months). Thirty-two patients were treatment-naive, 20 were treated for newly diagnosed intrahepatic failure, and 38 were treated for residual or recurrent HCC as salvage therapy. Thirty-two patients did not receive TACE, 48 received insufficient TACE, and 10 attained full lipiodol accumulation. The 3-year local control rate was 96.3%, the 3-year liver-related cause-specific survival rate was 72.5%, and the overall survival rate was 66.7%. Grade 3 laboratory abnormalities were observed in 6 patients, and 8 patients had Child-Pugh scores that worsened by 2 points.
CONCLUSIONS: SBRT achieved high local control and overall survival with feasible toxicities for patients with solitary HCC, despite rather stringent conditions. SBRT can be effective against solitary HCC in treatment-naive, intrahepatic failure, residual disease, and recurrent settings, taking advantage of its distinctive characteristics.

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

Completed

Date of protocol fixation

2007

Year

03

Month

15

Day

Date of IRB

Anticipated trial start date

2007

Year

04

Month

01

Day

Last follow-up date

2015

Year

05

Month

15

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2007

Year

03

Month

16

Day

Last modified on

2016

Year

04

Month

16

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000774