UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016226 |
|---|---|
| Receipt number | R000018146 |
| Scientific Title | Prospective observational study on the efficacy and safety of EPA in advanced gastric cancer patients treated by S-1+CDDP as first line. |
| Date of disclosure of the study information | 2015/01/15 |
| Last modified on | 2017/11/02 20:07:19 |
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Basic information
Public title
Prospective observational study on the efficacy and safety of EPA in advanced gastric cancer patients treated by S-1+CDDP as first line.
Acronym
Prospective observational study on the efficacy and safety of EPA in advanced gastric cancer patients treated by S-1+CDDP as first line.
Scientific Title
Prospective observational study on the efficacy and safety of EPA in advanced gastric cancer patients treated by S-1+CDDP as first line.
Scientific Title:Acronym
Prospective observational study on the efficacy and safety of EPA in advanced gastric cancer patients treated by S-1+CDDP as first line.
Region
| Japan |
Condition
Condition
gastric cancer
Classification by specialty
| Gastroenterology | Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
This study will evaluate the efficacy and safety of EPA in combination with S-1+CDDP for patients with advanced gastric cancer. In addition, early diagnosis method of cancer cachexia is considered exploratory.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
time to treatment failure(TTF) of a first-line chemotherapy
Key secondary outcomes
rate of weight loss, alteration in nutritional status, alteration in Glasgow Prognostic score, QOL(Quality of life), adverse events, progression free survival, response rete, relative dose intense, translational research
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 |
Interventions/Control_1
icosapentaenoic acid (EPA)
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
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
(1)Patients with clinically(radiographically/histologically/cytologically)proved adenocarcinoma of advanced gastric cancer and esophagogastric cancer
(2)Patients who can intake orally
(3)Patients without pretreatment for gastric cancer
(4)Patients without previous chemotherapy for malignant tumor except for gastric cancer and radiation therapy to the abdominal legion
(5)Patients with assessable lesion as defined by the Recist ver1.1 criteria
(6)20-75 year-old at informedconsent
(7)ECOG performance status(PS) 0-2
(8)Adequate bone marrow and organ function as defined as below
-leukocyte count>=3000/mm3
-neutrophil count>=1500/mm3
-hemoglobin level>=8.0g/dL
-platelet count>=100000/mm3
-AST and ALT=<100IU/L or AST and ALT=<200IU/L with liver metastases
-total bilirubin=<1.5mg/dL
-serum creatinin=<upper limit of average level in each facility, creatinin clearance>=50ml/min
(10)Written informed consent obtained from patients
Key exclusion criteria
(1)Patients with active bleeding or beedingtendency
(2)Patients who receive anticoagulant or antiplatelet drug
(3)Patients without prior therapy with drugs or supplements contained icosapentaenoic acid
(4)Patients with a history of allergy to icosapentaenoic acid
(5)Patients scheduled for surgery
(6)Patients scheduled for immune therapy
(7)Patients with serious complication
(8)Patients with immune-mediated illness
(9)Patients with digestive symptom by ileus or gastrointestinal bleeding
(10)Patients with symptomatic brain metastases or carcinomatous meningitis
(11)Patients with massive pericardial effusion, pleural effusion or ascites
*except for patients if effusions and ascites did not accumulate for more than two weeks after dranage therapy
*include patients if pleurosclerosis was performed with anticancer drugs except OK-432
(12)Metachronous and synchronous double cancer
(13)Bood tests positive for HBs antigen
(14)Patients who receive continuous corticosteroid administration
(15)Patients who receive drugs interact with S-1 or cisplatin
(16)Uncontrolled psychiatry disease
(17)Pregnant or lactating female and men who want to get partner pregnant
(18)Judged inappropriate by the investigators
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Keita Uchino |
Organization
Kyushu medical center
Division name
medical oncology
Zip code
Address
1-8-1 Jigyouhama, Chuo-ku, Fukuoka 810-8563, Japan
TEL
092-852-0700
keitauch@kyumed.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kotoe Takayoshi |
Organization
Kyushu medical center
Division name
medical oncology
Zip code
Address
1-8-1 Jigyouhama, Chuo-ku, Fukuoka 810-8563, Japan
TEL
092-852-0700
Homepage URL
t-kotoe@kyumed.jp
Sponsor or person
Institute
Kyushu medical center, medical oncology
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
九州医療センター
Kyushu medical center
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 01 | Month | 15 | 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
Completed
Date of protocol fixation
| 2013 | Year | 12 | Month | 18 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 12 | Month | 18 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 01 | Month | 15 | Day |
Last modified on
| 2017 | Year | 11 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018146
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
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