UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000855 |
|---|---|
| Receipt number | R000001028 |
| Scientific Title | A phase II study to evaluate the effect on the combination chemotherapy of CPT-11 and S-1 for advanced/recurrent colon cancer which combines genetic analysis on adverse events (OGSG 0405) |
| Date of disclosure of the study information | 2007/10/25 |
| Last modified on | 2021/11/15 23:07:21 |
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Basic information
Public title
A phase II study to evaluate the effect on the combination chemotherapy of CPT-11 and S-1 for advanced/recurrent colon cancer which combines genetic analysis on adverse events (OGSG 0405)
Acronym
OGSG 0405
Scientific Title
A phase II study to evaluate the effect on the combination chemotherapy of CPT-11 and S-1 for advanced/recurrent colon cancer which combines genetic analysis on adverse events (OGSG 0405)
Scientific Title:Acronym
OGSG 0405
Region
| Japan |
Condition
Condition
Patients with advanced and/or recurrent colon cancer
Classification by specialty
| Gastroenterology | Hematology and clinical oncology | Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The effect and adverse events on the combination chemotherapy of CPT-11 and S-1 for advanced/recurrent colon cancer are evaluated, and the prediction of adverse events is explored through gene analysis.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
Response Rate
Key secondary outcomes
adverse events,
survival time,
Relative Performance,
Genomic instability
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
Day 1 Day 15 Day 21 Day 35
CPT-11 O O
S-1 |.....................|
**CPT-11 80mg/m2 on Day 1 and Day 15
**S-1 80-120mg/m2 between day 1 and day 21
It takes 35 days for one course including 14 days interval.
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. colon cancer proven histologically
2. with measurable lesion
3. with/without prior chemotherapy except CPT-11 and S-1
O the last prior therapy before more than 4 weeks of registration
O without any adverse events due to prior chemotherapy.
4. age: =>20 and 75=>
5. Performance Status: 0-2 (ECOG criteria)
6. more than 13 weeks of expected survival period
7. sufficient function of important organs
O WBC: >= 4,000 and =< 12,000/mm3
O Neutrophyl: >= 2,000/mm3
O Platelet: >= 100,000/mm3
O hemoglobin: >= 8.0g/dl
O sGOT,sGPT: 2.5 times of normal range in each institute
O sT.bil.: <= 1.5 mg/dl
O sCreatinin: <= upper limit of each institute
O Cockcroft-Gault(Ccr): >=50ml/min
O ECG: normal range
8. with ability of oral intake
9. written informed consent
Key exclusion criteria
1. without interstitial pneumonia or pulmonary fibrosis on X-ray examination
And/or clinical signs
2. Cavity fluid which needs drainage
3. with active double cancer except ca. in situ
4. with intestinal paralysis or obstruction
5. under watery diarrhea
6. with uncontrolled DM
7. with ischemic cardiac disease
8. with mental disorder which disturbs registration to this study
9. with infectious disease which needs treatment
10. patients who receive steroids treatment
11. Cardiac failure, liver dysfunction, or renal dysfunction which disturb
Registration to this study
12. with brain metastasis and the symptom due to the metastasis
13. pregnant women or women who like to be pregnant
14. history of severe allergy against drug
15. doctor's dicision not to be registered to this study
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tomita Naohiro |
Organization
Kansai Rosai Hospital
Division name
Dpt.Surgery
Zip code
Address
660-8511 3-1-69, Inabaso, Amagasaki-shi, Hyogo
TEL
06-6416-1221
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 | 10 | Month | 25 | 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 | 10 | Month | 18 | Day |
Date of IRB
Anticipated trial start date
| 2005 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2008 | Year | 01 | Month | 01 | Day |
Date of closure to data entry
| 2008 | Year | 01 | Month | 01 | Day |
Date trial data considered complete
| 2008 | Year | 01 | Month | 01 | Day |
Date analysis concluded
| 2008 | Year | 01 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2007 | Year | 10 | Month | 18 | 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=R000001028
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