UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000693 |
|---|---|
| Receipt number | R000000830 |
| Scientific Title | Phase II study of second-line chemotherapy using CPT-11 plus CDDP in patients with advanced/recurrent gastric cancer (OGSG 0504) |
| Date of disclosure of the study information | 2007/05/03 |
| Last modified on | 2021/11/15 22:46:06 |
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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 (OGSG 0504)
Acronym
OGSG0504
Scientific Title
Phase II study of second-line chemotherapy using CPT-11 plus
CDDP in patients with advanced/recurrent gastric cancer (OGSG 0504)
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
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
Sponsor or person
Institute
Osaka Gastrointestinal Cancer Chemotherapy Study Group (OGSG)
Institute
Department
Personal name
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
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
| 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=R000000830
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