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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000008631
Receipt No. R000010138
Scientific Title Multi-center, phase II study for combination therapy with weekly pacritaxel and 5'-DFUR in patients with unresectable or recurrent gastric cancer
Date of disclosure of the study information 2012/08/06
Last modified on 2012/08/06

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Basic information
Public title Multi-center, phase II study for combination therapy with weekly pacritaxel and 5'-DFUR in patients with unresectable or recurrent gastric cancer
Acronym Multi-center, phase II study for combination therapy with weekly pacritaxel and 5'-DFUR in patients with unresectable or recurrent gastric cancer
Scientific Title Multi-center, phase II study for combination therapy with weekly pacritaxel and 5'-DFUR in patients with unresectable or recurrent gastric cancer
Scientific Title:Acronym Multi-center, phase II study for combination therapy with weekly pacritaxel and 5'-DFUR in patients with unresectable or recurrent gastric cancer
Region
Japan

Condition
Condition Advanced or recurrent gastric cancer
Classification by specialty
Gastroenterology Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate clinical usefulness of combination chemotherapy with weekly paclitaxel and 5'-DFUR in advanced or recurrent gastric cancer.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes Response Rate
Key secondary outcomes Overall survival(OS), Progression-free survival(PFS), Time to Treatment Failure(TTF), Adverse Effect

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
Medicine
Interventions/Control_1 The treatment included PTX 70 mg/m2 i.v. on days 1, 8, and 15 every 4 weeks and 5'-DFUR 600 mg/body p.o. everyday
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

Not applicable
Gender Male and Female
Key inclusion criteria 1) Histologically proven unresectable or recurrent gastric cancer.
2) ECOG Performance status:0-2
3) Up to one prior chemotherapy
4) 4 weeks rest after prior chemotherapy
5) Measurable disease or non-measurable but assessable disease according to the Response Evaluation Criteria in Solid Tumors. (RECIST)
6) Adequate organ functions:
i) hemoglobin >=9.0g/dL,
ii) WBC >=4000/mm3,
iii) neutrophils >=2000/mm3,
iv) platelets >=100,000/mm3,
v) AST(GOT)/ALT(GPT) <=2.5 X UL,
vi) total bilirubin <=1.5mg/dL,
vii) creatinine <=1.5mg/dL,
7) Life expectancy of more than 3 months
8) Age greater than 20
9) Informed consent approved by IRB
Key exclusion criteria 1) Drug hypersensitivity.
2) Infection and inflammation.
3) Prior infusion of paclitaxel
4) Peripheral neuropathy
5) Active synchronous malignancy.
6) Brain metastasis.
7) Severe mental disorders.
8) Symptomatic pulmonary fibrosis or interstitial pneumonia.
9) Severe systemic edema.
10) A large amount of pleural effusion or peritoneal fluid.
11) Severe heart disease.
12) Myocardial infarction within six months.
13) DM with insulin injection.
14) Pregnant patient
Target sample size 45

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masaaki Oka
Organization Yamaguchi University Graduate School of Medicine
Division name Department of Digestive Surgery and Surgical Oncology
Zip code
Address 1-1-1 Minamikokushi, Ube, Yamaguchi 755-8505, Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Shigefumi Yoshino
Organization Yamaguchi University Graduate School of Medicine
Division name Department of Digestive Surgery and Surgical Oncology
Zip code
Address 1-1-1 Minamikokushi, Ube, Yamaguchi 755-8505, Japan
TEL 0836-22-2264
Homepage URL
Email

Sponsor
Institute Department of Digestive Surgery and Surgical Oncology, Yamaguchi University Graduate School of Medicine
Institute
Department

Funding Source
Organization Department of Digestive Surgery and Surgical Oncology, Yamaguchi University Graduate School of Medicine
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
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 08 Month 06 Day

Related information
URL releasing protocol
Publication of results Partially published

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
2004 Year 02 Month 26 Day
Date of IRB
Anticipated trial start date
2004 Year 03 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 08 Month 06 Day
Last modified on
2012 Year 08 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010138

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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