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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000024004
Receipt No. 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 2019/03/15

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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, Chu-goku Cancer 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 Hiroshima University Hospital
Division name Dept, of Gastroenterological surgery
Zip code 734-0026
Address 1-2-3, Kasumi, Minami-ku, Hiroshima
TEL 082-257-5222
Homepage URL
Email ktanabe2@hiroshima-u.ac.jp

Sponsor
Institute Hiroshima Surgical Study group of Clinical Oncology (HiSCO)
Institute
Department

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 Chu-Goku Cancer Center
Address 3-1 Aoyama-cho Kure City, Hiroshima, Japan
Tel +81-823-22-3111
Email takahsuzuki@yahoo.co.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
2023 Year 12 Month 31 Day
Date of closure to data entry
2023 Year 12 Month 31 Day
Date trial data considered complete
2023 Year 12 Month 31 Day
Date analysis concluded
2023 Year 12 Month 31 Day

Other
Other related information

Management information
Registered date
2016 Year 09 Month 11 Day
Last modified on
2019 Year 03 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026371

Research Plan
Registered date File name
2018/05/28 (最終版)HiSCO 06-A PII計画書ver1.0.pdf

Research case data specifications
Registered date File name

Research case data
Registered date File name


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