UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000024004
Receipt number R000026371
Scientific Title Phase II clinical trial of surgical intervention following chemotherapy for synchronous and metachronous liver metastasis from gastric cancer.(HiSCO 06)
Date of disclosure of the study information 2016/09/11
Last modified on 2024/03/17 13:15:36

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Basic information

Public title

Phase II clinical trial of surgical intervention following chemotherapy for synchronous and metachronous liver metastasis from gastric cancer.(HiSCO 06)

Acronym

Phase II clinical trial of surgical intervention for liver metastasis from gastric cancer.(HiSCO 06)

Scientific Title

Phase II clinical trial of surgical intervention following chemotherapy for synchronous and metachronous liver metastasis from gastric cancer.(HiSCO 06)

Scientific Title:Acronym

Phase II clinical trial of surgical intervention for liver metastasis from gastric cancer.(HiSCO 06)

Region

Japan


Condition

Condition

Patients with synchronous or metachronous liver metastasis from gastric cancer

Classification by specialty

Gastroenterology Hepato-biliary-pancreatic medicine Gastrointestinal surgery
Hepato-biliary-pancreatic surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To evaluate efficacy of surgical intervention for liver metastastic lesion in the gastric cancer patients, who underwent systemic chemotherapy. To evaluate complete resection rate, safety of surgical intervention, and prognosis of patients who achieved complete resection.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Explanatory

Developmental phase

Phase II


Assessment

Primary outcomes

relapse free survival rate for 3 years

Key secondary outcomes

Rate of complete resction (surgical resection), and rate of curative treatment (include intervention of RFA or MCT) for hepatic lesion
operative morbidigy and mortality
length of postoperative hospital stay
quality of life


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Maneuver

Interventions/Control_1

hepatectomy

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

80 years-old >=

Gender

Male and Female

Key inclusion criteria

1. Histologically proven primary gastric adenocarcinoma.
2. Stage IV gastric cancer patients initially regarded as resectable, underwent radical operation after chemotherapy (neoadjuvant case).

Key exclusion criteria

Stage IV gastric cancer patients with peritoneal dissemination, or positive cytology
para aolta LN netastasis.
Patients whom doctors consider unsuitable

Target sample size

30


Research contact person

Name of lead principal investigator

1st name Takahisa
Middle name
Last name Suzuki

Organization

National Hospital Organization, Kure Medical Center

Division name

Department of Surgery

Zip code

737-0023

Address

3-1 Aoyama-cho. Kure City, Hiroshima, 737-0023, Japan

TEL

+81-823-22-3111

Email

takahsuzuki@yahoo.co.jp


Public contact

Name of contact person

1st name Kazuaki
Middle name
Last name Tanabe

Organization

Graduate School of Biomedical and Health Sciences, Hiroshima University

Division name

Department of Perioperative and Clitical Management

Zip code

734-8551

Address

1-2-3, Kasumi, Minami-ku, Hiroshima

TEL

082-257-5222

Homepage URL


Email

ktanabe2@hiroshima-u.ac.jp


Sponsor or person

Institute

Hiroshima Surgical Study group of Clinical Oncology (HiSCO)

Institute

Department

Personal name



Funding Source

Organization

Hiroshima University Hospital

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

National Hospital organization Kure Medical Center

Address

3-1 Aoyama-cho Kure City, Hiroshima, Japan

Tel

+81-823-22-3111

Email

takahisa-suzuki@umin.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



Other administrative information

Date of disclosure of the study information

2016 Year 09 Month 11 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

2016 Year 09 Month 11 Day

Date of IRB

2016 Year 09 Month 09 Day

Anticipated trial start date

2016 Year 09 Month 11 Day

Last follow-up date

2027 Year 05 Month 30 Day

Date of closure to data entry

2027 Year 06 Month 30 Day

Date trial data considered complete

2027 Year 06 Month 30 Day

Date analysis concluded

2027 Year 06 Month 30 Day


Other

Other related information



Management information

Registered date

2016 Year 09 Month 11 Day

Last modified on

2024 Year 03 Month 17 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026371


Research Plan
Registered date File name
2020/07/20 HiSCO 06-A PII計画書ver3.0.doc

Research case data specifications
Registered date File name

Research case data
Registered date File name