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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000002988
Receipt No. R000003613
Scientific Title A Phase II Study of Paclitaxel+Cisplatin+5-Fluorouracil in Unresectable Advanced or Recurrent Gastric Cancer
Date of disclosure of the study information 2010/01/06
Last modified on 2010/01/05

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Basic information
Public title A Phase II Study of Paclitaxel+Cisplatin+5-Fluorouracil in Unresectable Advanced or Recurrent Gastric Cancer
Acronym TCF-P2
Scientific Title A Phase II Study of Paclitaxel+Cisplatin+5-Fluorouracil in Unresectable Advanced or Recurrent Gastric Cancer
Scientific Title:Acronym TCF-P2
Region
Japan

Condition
Condition Unresectable Advanced or Recurrent Gastric Cancer
Classification by specialty
Gastroenterology Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The present multicenter phase II study was conducted to confirm the efficacy of paclitaxel/cisplatin/5-FU in advanced gastric cancer.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Response rate
Key secondary outcomes

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 paclitaxel+cisplatin+5-FU
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 a) pathologically confirmed gastric carcinoma
b)measurable lesion(s)
c) absence of any history of treatment with taxanes, platinum-based compounds, or 5-fluorouracil (one regimen of pretreatment with oral 5-fluorouracil agents was allowed)
d) ECOG PS 0-2
e) adequate organ function
f) written informed consent.
Key exclusion criteria a) serious complications e.g. ischemic heart disease which is in need of treatment
b) myocardial infarction developed within 6 momnths
c) liver cirrhosis
d) interstitial pneumonitis or pulmonary fibrosis which is in need of oxygen therapy
e) fresh GI bleeding treated with repeated transfusion
f) uncontrollable DM
h) ileus
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kenji Omura
Organization Kanazawa University
Division name Genneral and Cardiopulmonary Surgery
Zip code
Address 13-1 Takaramachi, Kanazawa, 920-8641 JAPAN
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Nagoya Graduate Scholl of Medicine
Division name Department of Social Life Science
Zip code
Address
TEL 052-744-2442
Homepage URL
Email

Sponsor
Institute Non profit foundation: Epidemiological and Clinical Research Information Network
Institute
Department

Funding Source
Organization Non profit foundation: Epidemiological and Clinical Research Information Network
Organization
Division
Category of Funding Organization Non profit foundation
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
2010 Year 01 Month 06 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
2006 Year 01 Month 13 Day
Date of IRB
Anticipated trial start date
2006 Year 01 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
2010 Year 01 Month 06 Day
Last modified on
2010 Year 01 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003613

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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