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 | 2025/03/19 09:12:53 |
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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
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
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
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
30
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
No longer 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
| 2025 | Year | 03 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026371
