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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000000723
Receipt No. R000000865
Scientific Title Feasibility study of weekly paclitaxelin patients with pre-treatment (2 regimen) advanced / recurrent gastric cancer.
Date of disclosure of the study information 2007/06/01
Last modified on 2009/12/04

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Basic information
Public title Feasibility study of weekly paclitaxelin patients with pre-treatment (2 regimen) advanced / recurrent gastric cancer.
Acronym OGSG 0602
Scientific Title Feasibility study of weekly paclitaxelin patients with pre-treatment (2 regimen) advanced / recurrent gastric cancer.
Scientific Title:Acronym OGSG 0602
Region
Japan

Condition
Condition Advanced / Recurrent gastric cancer.
Classification by specialty
Gastroenterology Hematology and clinical oncology Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 A phase II study, that the feasibility and response of TS-1 + CPT-11 for advanced and/or recurrent gastric cancer as the third line therapy are evaluated.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes feasibility of the treatment (ratio of completion)
Key secondary outcomes Incidence of adverse events, Response Rate,Time to treatment failure,Progression free survival, Overall survival

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Premedication: Dexamethazon 20mg should be administered 30 minutes before
Paclitaxel therapy
Paclitaxel is administered on day 1, 8, and day 15 in one course of 28 days.
It will be repeated until treatment stop.
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 1. histologically proven gastric carcinoma
2. patients who received TS-1 or CPT-11 as a prior chemotherapy and enough treatment free period (TS-1: 2weeks, CPT-11: 2weeks)
3. with measurable lesions
4. age: 20<= years old
5. PS(ECOG): 0 &#8211; 2
6. without any other severe diseases
WBC 3,000<=
Neutrocyte 1,500mm3<=
Hemoglobin 9.0 g.dl <=
Platelet 100,000/mm3 <=
Total bilirubin 1.5 mg/dl =>
AST, ALT within five times of normal range in each institute
Serum creatinin 1.5 mg/dl >=
ECG normal range
7. expected survival period: longer than 3 months
8. written informed consents
Key exclusion criteria 1. cavity fluid which should be taken out
2. with double cancer and/or multiple cancer
3. patients with disorders on peripheral nerves
4. with active infectious disease which needs treatment
5. under the condition of diarrhea
6. with some mental and/or neural disorder which disturbs registration
7. under continuous steroids therapy
8. with other severe diseases(intestinal paralysis, intestinal obstruction,
uncontrolled DM, pulmonary fibrosis, cardiac failure, or liver dysfunction)
9. pregnant and/or nursing women
10.with allergic history against medicines
11.with severe allergic response against medicine including cremoful
12.under Docetaxel or Paclitaxel therapy
13.doctors' stop not to register to the study
Target sample size 22

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Taro Sato
Organization Kinki University school of medicine
Division name Dpt. Oncology
Zip code
Address 377-2 Oono-higashi, Osakasayama-shi, Osaka 589-8511
TEL 072-366-0221
Email

Public contact
Name of contact person
1st name
Middle name
Last name Furukawa Hiroshi
Organization Sakai City Hospital
Division name Director
Zip code
Address 1-1-1,Minamiyasuicho,Sakai-ku,Sakai, 590-0064
TEL 072-221-1700
Homepage URL
Email

Sponsor
Institute OGSG
Institute
Department

Funding Source
Organization NPO Osaka Chinical Study Supporting Organization
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
2007 Year 06 Month 01 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 04 Month 25 Day
Date of IRB
Anticipated trial start date
2006 Year 09 Month 01 Day
Last follow-up date
2009 Year 09 Month 01 Day
Date of closure to data entry
2009 Year 09 Month 01 Day
Date trial data considered complete
2009 Year 09 Month 01 Day
Date analysis concluded
2009 Year 09 Month 01 Day

Other
Other related information

Management information
Registered date
2007 Year 05 Month 24 Day
Last modified on
2009 Year 12 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000865

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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