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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN C000000286
Receipt No. R000000366
Scientific Title Phase II Study of bi-weekly Paclitaxel (TAXOL)for fluorouracil resistant advanced and recurrent Gastric Cancer
Date of disclosure of the study information 2005/11/18
Last modified on 2008/04/22

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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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