UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011445 |
|---|---|
| Receipt number | 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 17:27:08 |
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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
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
nshinno@gesurg.med.osaka-u.ac.jp
Sponsor or person
Institute
Department of Surgery, Osaka University Graduate School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009330
