UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | C000000286 |
|---|---|
| Receipt number | 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 13:41:33 |
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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
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
Sponsor or person
Institute
The Tokyo Cooperative Oncology Group
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000366
