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UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000011445
Receipt No. R000009330
Scientific Title Phase II clinical trial of surgical intervention following chemotherapy for synchronous and metachronous liver metastasis from gastric cancer.
Date of disclosure of the study information 2013/08/10
Last modified on 2015/09/15

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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.
Acronym Phase II clinical trial of surgical intervention for liver metastasis from gastric cancer.
Scientific Title Phase II clinical trial of surgical intervention following chemotherapy for synchronous and metachronous liver metastasis from gastric cancer.
Scientific Title:Acronym Phase II clinical trial of surgical intervention for liver metastasis from gastric cancer.
Region
Japan

Condition
Condition Patients with synchronous or metachronous liver metastasis from gastric cancer
Classification by specialty
Gastroenterology Gastrointestinal surgery Hepato-biliary-pancreatic surgery
Not applicable
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 neo-adjuvant 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 Three years overall survival rate of patient who achieved curative treatment.
Key secondary outcomes Rate of complete resction (surgical resection), and rate of curative treatment (include intervention of RFA or MCT) for hepatic lesion. Safety of procedure (rate of intra/post operative adverse events), recurrence-free survival time of curative treatment case, and overall survival time of registered patients.

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine Maneuver
Interventions/Control_1 (A) Neo-adjuvant chemotherapy (2-4 kur): Attending physician selects one of the 3 regimen below.
(1)SP: S-1 (80mg/m2/day, d1-21)+ Cisplatin (60mg/m2, d8) / 5W,
(2)DCS: S-1 (80mg/m2/day, d1-14) + Cisplatin (60mg/m2, d1) + Docetaxel (40mg/m2, d1) /4W, (3)XP+Her: Capecitabine (2000mg/m2/day, d1-14) + Cisplatin (80mg/m2, d1) +
Trastuzumab (first time; 8 mg/kg, second and subsequent; 6mg/kg) /3W.
(B) Surgical intervention: (1)Primary lesion; total gastrectomy, distal gastrectomy, and proxymal gastrectomy, with more than D2 lymph node dissection. (2)Metastatic lesion; Partial hepatectomy is the basic treatment, but segment resection or lobectomy will considered if necessary. Moreover, RFA or MCT will be permitted only when curtive treatment can be expected.
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) Patients with synchronous or metachronous liver metastasis from gastric cancer.
2) Number of liver metastatic lesion is no more than 4.
3) Maximal diameter of liver metastatic lesion is no more than 5 cm.
4) Performance status is 0-2.
5) There is no evidence of peritoneal dissemination and no metastatic lesion other than liver.
Key exclusion criteria 1) Patients with difficulty in oral intake.
2) Patients with contraindication for administration of S-1, Cisplatin, Docetaxel, Capecitabine, Trastuzumab, and 5 FU.
3)Patients with other kinds of active cancers overlapping gastric cancer.
4) Patients with evidence of peritoneal dissemination or metastatic lesion other than liver (eg. bone, brain).
5) Patients with a history of bone metastasis.
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yuichiro Doki
Organization Osaka University Graduate School of Medicine, Osaka, Japan
Division name Department of Gastroenterological Surgery
Zip code
Address 2-2-E2, Yamadaoka, Suita, Osaka 565-0871, Japan
TEL +81668793251
Email ydoki@gesurg.med.osaka-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Shinno Naoki
Organization Osaka University Graduate School of Medicine, Osaka, Japan
Division name Department of Gastroenterological Surgery
Zip code
Address Department of Gastroenterological Surgery,Osaka University Graduate School of Medicine, Osaka, Japan
TEL +81668793251
Homepage URL
Email nshinno@gesurg.med.osaka-u.ac.jp

Sponsor
Institute Department of Surgery, Osaka University Graduate School of Medicine
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2013 Year 08 Month 10 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
2011 Year 11 Month 14 Day
Date of IRB
Anticipated trial start date
2011 Year 11 Month 14 Day
Last follow-up date
2017 Year 11 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2013 Year 08 Month 10 Day
Last modified on
2015 Year 09 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009330

Research Plan
Registered date File name
2015/02/26 胃がん肝転移.zip

Research case data specifications
Registered date File name

Research case data
Registered date File name


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