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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000000855
Receipt No. 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
Date of disclosure of the study information 2007/10/25
Last modified on 2008/08/21

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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
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
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
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 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
2008 Year 08 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001028

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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