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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000008395
Receipt No. R000009871
Scientific Title QOL measurement of Capecitabine/CDDP or S-1/CDDP in patients with Advanced Gastric Cancer -A Pilot study-
Date of disclosure of the study information 2012/07/10
Last modified on 2012/07/10

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Basic information
Public title QOL measurement of Capecitabine/CDDP or S-1/CDDP in patients with Advanced Gastric Cancer -A Pilot study-
Acronym QOL measurement of Capecitabine/CDDP or S-1/CDDP in patients with Advanced Gastric Cancer -A Pilot study-
Scientific Title QOL measurement of Capecitabine/CDDP or S-1/CDDP in patients with Advanced Gastric Cancer -A Pilot study-
Scientific Title:Acronym QOL measurement of Capecitabine/CDDP or S-1/CDDP in patients with Advanced Gastric Cancer -A Pilot study-
Region
Japan

Condition
Condition Gastric Cancer
Classification by specialty
Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 QOL measurement of Capecitabine/CDDP or S-1/CDDP in patients with Advanced Gastric Cancer
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes QOL evaluation
Key secondary outcomes

Base
Study type Interventional

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

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Capecitabin+CDDP (XP)
Day1 to 14:Capecitabin take orally(twicw a day)
Day1 CDDP:Drip infusion
Day15 to 21:7 days rest
Interventions/Control_2 S-1+CDDP (SP)
Day1 to 21:S-1 take orally(twicw a day)
Day8:CDDP 60mg/m2 Drip infusion
Day22 to 35:14 days rest
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)proven gastric adenocarcinoma R0 unresectable or reccurent gastric cancer
2)HER2 negative or unknown gastric cancer
3)patients between 20 and 75 years old
4)PS(ECOG) between 0 and 2
5)patients who not undergo chemotherapy and/or radiation therapy
6)with a good condition of important organs recent 14 days
1.WBC>=3,000/mm3
2.neutrophil>=1,500/mm3
3.platelet>=100,000/mm3
4.hemoglobin>=8.0g/dl
5.total bilirubin<=1.5mg/dl
6.AST(GOT)<=100IU/L (with hepatic metastasis <=150)
7.ALT(GPT)<=100IU/L (with hepatic metastasis <=150)
8.serum creatinine<=1.2mg/dl
9.creatinin clearance>=60ml/min
7)expected survival longer than 3 months
8)patients who can take orally
9)written informed consent to participate in this study
Key exclusion criteria 1)with prior chemotherapy and/or radiation therapy
2)patients administrated fluoropyrimidine before less than 6 months of the registration
3)with a history of platinum administrarion
4)simultaneous double cancer or sequential double cancer whose interstitial period is shorter than 5 years.Carcinoma in situ or Cancers localized in membranous layer are not included to double cancer.
5)with symptoms of brain metastasis
6)with history of severe allergy against medicines
7)with following diseases
1.uncontrolled DM
2.uncontrolled high-blood pressure
3.liver cirrhosis and/or liver failure
4.renal failure
5.interstitial pneumonitis, pulmonary fibrosis, severe athelectasis
6.active infection diseases
7.heart failure, cardic infarction and/or severe disorder on ECG during recent 6 months
8)HBs positive status
9)with severe diarrhea (watery stool over 4 times a day)
10)patients who have flucytosine, fenitoin or walfarin
11)patients who have steroids continuously
12)women pregnant or women who like to be pregnant or males who like to have their own baby
13)patients decided not to register to this study due to psychologic diseases and/or psychological symptoms
14)patients whom doctor decide not ro register to this study
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Koji Nakai
Organization Kansai Medical University
Division name Department of surgery
Zip code
Address 10-15, Fumizono-cho, Moriguchi City, Osaka, Japan
TEL 06-6992-1001
Email

Public contact
Name of contact person
1st name
Middle name
Last name Koji Nakai
Organization Kansai Medical University
Division name Department of surgery
Zip code
Address 10-15, Fumizono-cho, Moriguchi City, Osaka, Japan
TEL 06-6992-1001
Homepage URL
Email nakaik@takii.kmu.ac.jp

Sponsor
Institute Kansai Medical University
Institute
Department

Funding Source
Organization Kansai Medical University
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
2012 Year 07 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 Preinitiation
Date of protocol fixation
2012 Year 03 Month 06 Day
Date of IRB
Anticipated trial start date
2012 Year 08 Month 01 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
2012 Year 07 Month 10 Day
Last modified on
2012 Year 07 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009871

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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