UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002988 |
|---|---|
| Receipt number | 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 17:31:10 |
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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
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
Sponsor or person
Institute
Non profit foundation: Epidemiological and Clinical Research Information Network
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003613
