UMIN-CTR Clinical Trial

Basic information
Public title	Phase II Study of bi-weekly Paclitaxel (TAXOL)for fluorouracil resistant advanced and recurrent Gastric Cancer
Acronym	Phase II Study of bi-weekly Paclitaxel (TAXOL)for fluorouracil resistant advanced and recurrent Gastric Cancer
Scientific Title	Phase II Study of bi-weekly Paclitaxel (TAXOL)for fluorouracil resistant advanced and recurrent Gastric Cancer
Scientific Title:Acronym	Phase II Study of bi-weekly Paclitaxel (TAXOL)for fluorouracil resistant advanced and recurrent Gastric Cancer
Region	Japan

Condition
Condition	5-fluorouracil resistant advanced and recurrent Gastric Cancer
Classification by specialty	Gastroenterology Gastrointestinal surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	Effectiveness and the safety are examined of bi-weekly Paclitaxel (TAXOL)for fluorouracil resistant advanced and recurrent Gastric Cancer.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase	Phase II

Assessment
Primary outcomes	Response Rate
Key secondary outcomes	Adverse events, OS, TTP

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	TXL 140mg/m2/week iv, day1.15 q 4weeks
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	80 years-old >=
Gender	Male and Female
Key inclusion criteria	1) With pathologically proven gastric cancer 2) ECOG performance status of 0-2 3) With at least one measurable lesion (RECIST) 4)Cases with previous treatment containing 5- fluorouracil, and was refractory or recurrent (limited to only 1 course and the interval was required for more than 2 weeks) 5) With adequate bone marrow, cardiac, respiratory, hepatic, and renal functions. 6) No Accompanied serious diseases, No Active secondary cancer 7) Age 20-80 years 8) With written informed consent
Key exclusion criteria	1) Accompanied serious diseases 2) A past history of drug allergy 3) A past history of allergic reaction to polyoxy-ethilen oil 4) Acute inflammatory disease 5) Peripheral neuropathy 6) Pregnancy or breast feeding 7) Concomitant malignancy. It influences survival, adverse events 8) Symptomatic brain metastasis 9) hypersensitivity to alcohol
Target sample size	40

Research contact person
Name of lead principal investigator	1st name Middle name Last name Wasaburo Koizumi
Organization	Kitazato Univercity East Hospital
Division name	Digestive Internal Medicine
Zip code
Address	2-1-1 Asamizodai Sagamihara-shi Kanagawa Japan
TEL
Email

Public contact
Name of contact person	1st name Middle name Last name
Organization	The Tokyo Cooperative Oncology Group
Division name	Secretariat
Zip code
Address
TEL
Homepage URL
Email

Sponsor
Institute	The Tokyo Cooperative Oncology Group
Institute
Department

Funding Source
Organization	The Tokyo Cooperative Oncology Group
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	2005 Year 11 Month 18 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	2005 Year 05 Month 10 Day
Date of IRB
Anticipated trial start date	2005 Year 06 Month 01 Day
Last follow-up date	2008 Year 03 Month 01 Day
Date of closure to data entry	2008 Year 04 Month 01 Day
Date trial data considered complete	2008 Year 04 Month 01 Day
Date analysis concluded	2008 Year 04 Month 01 Day

Other
Other related information

Management information
Registered date	2005 Year 11 Month 18 Day
Last modified on	2008 Year 04 Month 22 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000366

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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