UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Phase II study of combination therapy with Irinotecan and S-1 in patients with progressive colorectal cancer after FOLFOX regimen
Title of the study (Brief title)	Phase II study of combination therapy with Irinotecan and S-1 in patients with progressive colorectal cancer after FOLFOX regimen(KSCC0702)
Region	Japan

Condition
Condition	Unresectable advanced/recurrent colorectal cancer
Classification by specialty	Gastroenterology Hepato-biliary-pancreatic medicine Hematology and clinical oncology Gastrointestinal surgery Hepato-biliary-pancreatic surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	Safety and efficacy of combination therapy with Irinotecan and S-1 in patients with progressive colorectal cancer after FOLFOX regimen
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase	Phase II

Assessment
Primary outcomes	RR
Key secondary outcomes	Safety, PFS, OS

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Irinotecan+S-1, repeated every 3 weeks.
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.colorectal cancer, cytologically and/or histrogically, and Unresectable advanced/recurrent colorectal cancer 2.2nd-line after FOLFOX base chemotherapy 3.the last prior therapy before more than 2 weeks of registration 4.no prior radiotherapy 5.age: 20-75 years old 6.Performance Status (ECOG): 0-2 7.with measurable lesions 8.Life expectancy estimated >= 3 months 9.Sufficient organ functions 10.witten informed consents
Key exclusion criteria	1. Administering antithrobotic drug within 7 days 2. Serious complications (renal failure or hepatic failure) 3. Serious drug hypersensitivity or a history of drug allergy 4. Active concomitant malignancy 5. Active infections 6. High blood pressure and diabetic that cannot be controlled 7. symptomatic or asymptomatic but treated heart disease 8. interstitial pnumonitis, pulmonary fibrosis or high-grade pulmonary emphysema 9. histry of mental disturbances or cerebrovascular attach 10. Fresh hemorrhage from digestive tube, intestines tube paralysis, intestinal obstruction and peptic ulcer 11. Plerral effusion, peritoneal fluid and pericardial fluid 12. Symptomatic brain metastasis 13. Water solubility diarrhea, in case of the patient who has a colostomy, diarrhea impairs daily life activity 14. Need to treatment with atazanavir sulfate or flucytosine 15. under coutinuous steroid therapy 16. Pregnant women, possibly pregnant women, wishing to become pregnant, and nursing mothers 17. on other clinical trial 18. Other conditions not suitable for this study
Target sample size	56

Research contact person
Name of lead principal investigator	Maehara Yoshihiko
Organization	Kyushu University
Division name	Dpt. of surgery and science
Address	Maidashi 3-1-1, Higashi-ku, Fukuoka, 812-8582
TEL	092-631-2920
Email	kscc2@cres-kyushu.or.jp

Public contact
Name of contact person	KSCC
Organization	CReS
Division name	KSCC
Address	Maidashi 3-1-1, Higashi-ku, Fukuoka, 812-8582
TEL	092-631-2920
Homepage URL	http://www.ks-cc.jp/
Email	kscc2@cres-kyushu.or.jp

Sponsor
Institute	KSCC
Institute
Department

Funding Source
Organization	CReS
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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

九州大学 (福岡県) 国立病院機構九州医療センター (福岡県) 公立学校共済組合九州中央病院 (福岡県) 済生会福岡総合病院 (福岡県) 福岡歯科大学医科歯科総合病院 (福岡県) 産業医科大学 (福岡県) 新日鐵八幡記念病院 (福岡県) 社会保険田川病院 (福岡県) 社会保険仲原病院 (福岡県) 久留米大学 (福岡県) 久留米大学医療センター (福岡県) 社会保険久留米第一病院 (福岡県) 公立八女総合病院 (福岡県) 大牟田市立総合病院 (福岡県) 国立病院機構嬉野医療センター (佐賀県) 健康保険諫早総合病院 (長崎県) 白十字会　佐世保中央病院 (長崎県) 長崎大学 (長崎県) 長崎大学 (長崎県) 春回会　井上病院 (長崎県) 光晴会病院 (長崎県) 医理会　柿添病院 (長崎県) 済生会熊本病院 (熊本県) 熊本大学 (熊本県) 健康保険人吉総合病院 (熊本県) 大分県立病院 (大分県) 大分赤十字病院 (大分県) 国立病院機構大分医療センター (大分県) 国立病院機構別府医療センター (大分県) 大分大学 (大分県) 中津市立中津市民病院 (大分県) 小林市立病院 (宮崎県) 社会保険宮崎江南病院 (宮崎県) 国立病院機構南九州病院 (鹿児島県) 今給黎総合病院 (鹿児島県) 潤愛会　鮫島病院 (鹿児島県) 鹿児島大学 (鹿児島県) 鹿児島厚生連病院 (鹿児島県) 鹿児島共済会南風病院 (鹿児島県) 済生会川内病院 (鹿児島県) 出水郡医師会立阿久根市民病院 (鹿児島県) 県民健康プラザ鹿屋医療センター (鹿児島県) 鹿児島県立薩南病院 (鹿児島県) 中頭病院 (沖縄県) 沖縄県立南部医療センター・こども医療センター (沖縄県) 琉球大学 (沖縄県) 北部地区医師会病院 (沖縄県) 広島赤十字・原爆病院 (広島県) 松山赤十字病院 (愛媛県))

Other administrative information
Date of disclosure of the study information	2008 Year 08 Month 29 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2007 Year 08 Month 03 Day
Anticipated trial start date	2007 Year 08 Month 03 Day
Last follow-up date	2010 Year 07 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2008 Year 08 Month 29 Day
Last modified on	2017 Year 04 Month 30 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001629