UMIN-CTR Clinical Trial

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
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	2021 Year 11 Month 15 Day

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