UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000723 |
|---|---|
| Receipt number | R000000865 |
| Scientific Title | Feasibility study of weekly paclitaxel patients with pre-treatment (2 regimens) advanced/recurrent gastric cancer (OGSG 0602) |
| Date of disclosure of the study information | 2007/06/01 |
| Last modified on | 2021/11/15 22:55:46 |
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Basic information
Public title
Feasibility study of weekly paclitaxel patients with pre-treatment (2 regimens) advanced/recurrent gastric cancer (OGSG 0602)
Acronym
OGSG 0602
Scientific Title
Feasibility study of weekly paclitaxel patients with pre-treatment (2 regimens) advanced/recurrent gastric cancer (OGSG 0602)
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 – 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
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
Sponsor or person
Institute
OGSG
Institute
Department
Personal name
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
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
| 2021 | Year | 11 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000865
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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