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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000000693
Receipt No. R000000830
Scientific Title Phase II study of second line chemotherapy using CPT-11 plus CDDP in patients with advanced/recurrent gastric cancer
Date of disclosure of the study information 2007/05/03
Last modified on 2008/09/19

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Basic information
Public title Phase II study of second line chemotherapy using CPT-11 plus
CDDP in patients with advanced/recurrent gastric cancer
Acronym OGSG0504
Scientific Title Phase II study of second line chemotherapy using CPT-11 plus
CDDP in patients with advanced/recurrent gastric cancer
Scientific Title:Acronym OGSG0504
Region
Japan

Condition
Condition Advanced/Recurrent gastric cancer which has no response to S-1
Classification by specialty
Gastroenterology Hematology and clinical oncology Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 A phase II study to evaluate the effectiveness and feasibility of CPT-11 + CDDP
for patients with advanced/recurrent gastric cancer which has no response to S-1
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Antitumor response (Response Rate, Duration of response)
Key secondary outcomes 1) Adverse Events
2) Overall survival
3) Progression free survival;PFS
4) Time to treatment failure;TTF
5) Relative dose intensity

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 CPT-11(60mg/m2) and CDDP(30mg/m2) are administered on day 1, 15, 29, and 43, and more courses on every 14 days if patients can be tolerant and
have response (effective).

One course takes 14 days.
______________Day 1__________Day 15
CPT-11___60mg/m2______60mg/m2
CDDP______30mg/m2______30mg/m2
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
75 years-old >=
Gender Male and Female
Key inclusion criteria 1. gastric carcinoma diagnosed histologically
2. advanced and/or recurrent gastric cancer
3. gastric cancer which has no response to prior TS-1 therapy
a. progression during or after TS-1 therapy
b. recurrence within 26 weeks of the end of postoperative TS-1
therapy
4. without surgical operation or any therapies other than TS-1
5. with TS-1 therapy more than 4 weeks
6. more than 4 weeks rest after TS-1 therapy
7. with measurable lesion
8. age between 20 and 75 years old
9. Performance Status 0-2 (ECOG Classification)
10. more than 13 weeks of expected survival
11. with good function in the important organs
WBC: 4,000 <= and =>12,000/mm3
Neutrophil >= 2,000/mm3
Platelet >= 100,000 /mm3
Hb >= 8.0 g/dl
sGOT, sGPT: < normal range x 2.5
T Bil.: <= 1.5 mg/dl
sCreatinin <=Clearlance
12. written informed consent
Key exclusion criteria 1. with interstitial pneumonitis or pulmonary fibrosis
2. much fluid in the cavity
3. active double cancer except carcinoma in situ or skin cancer
4. with infectious disease which needs treatment
5. intestinal paralysis or ileus
6. watery stool (diarrhea)
7. uncontrolled DM or DM being treated by insulin
8. with ischemic cardiac disease
9. with psycologic disorder which disturbs recruiting to the study
10. with severe diseases (cardiac failure, liver dysfunction or renal dysfunction)
11. pregnant and/or nursing women
12. present and/or past allergy against medicines
13. doctor's decision not to recruit to the study
Target sample size 35

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hirao Motohiro
Organization National Hospital Organization Osaka National Hospital
Division name Dpt.Surgery
Zip code
Address 2-1-14,Houenzaka,Chuou-ku,Osaka,540-0006
TEL 06-6942-1331
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization National Hospital Orgamnzation
Division name Dpt.Surgery
Zip code
Address 2-1-14,Houenzaka,Chuou-ku,Osaka,540-0006
TEL 06-6942-1331
Homepage URL
Email

Sponsor
Institute Osaka Gastrointestinal Cancer Chemotherapy Study Group (OGSG)
Institute
Department

Funding Source
Organization Osaka Clinical 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 05 Month 03 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 06 Month 02 Day
Date of IRB
Anticipated trial start date
2005 Year 06 Month 01 Day
Last follow-up date
2007 Year 08 Month 01 Day
Date of closure to data entry
2007 Year 08 Month 01 Day
Date trial data considered complete
2008 Year 08 Month 01 Day
Date analysis concluded
2008 Year 08 Month 01 Day

Other
Other related information

Management information
Registered date
2007 Year 04 Month 26 Day
Last modified on
2008 Year 09 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000830

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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