UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Phase II study of S-1 plus irinotecan combined with bevacizumab as 2nd-line chemotherapy in patients with unresectable colorectal cancer, who had previously received oxaliplatin-based chemotherapy.
Title of the study (Brief title)	Phase II study of S-1 plus irinotecan combined with bevacizumab as 2nd-line chemotherapy in patients with unresectable colorectal cancer, who had previously received oxaliplatin-based chemotherapy.(KSCC1102)
Region	Japan

Condition
Condition	Colorectal cancer
Classification by specialty	Gastroenterology Gastrointestinal surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the efficacy and safety of S-1 plus irinotecan combined with bevacizumab in patients with unresectable colorectal cancer, who had previously received oxaliplatin-based chemotherapy.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2	Pragmatic
Developmental phase	Phase II

Assessment
Primary outcomes	Progression Free Survival
Key secondary outcomes	Response rate Overall Survival Time to Treatment Failure Safety Investigation of Nausea and vomiting Quality of life

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	CPT-11 150mg/m2 i.v. (day1) Bev 7.5mg/kg i.v. (day1) S-1 80mg/m2 p.o. (day1-14) to be 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	Not applicable
Gender	Male and Female
Key inclusion criteria	1) Written informed consent 2) Appropriate for the study at the physician's assessment 3) Histopathology confirmed colorectal cancer. 4) Previously received oxaliplatin-based chemotherapy as 1st-line chemotherapy. 5) No prior radio-therapy for target lesion. 6) Aged 20<= years 7) ECOG performance status of 0-1. 8) At least one measurable lesion based on the RECIST criterion. (within 28 days before registration). 9) Be able to take oral drugs 10) Required baseline laboratory parameters (within 14 days before registration): WBC: >= 3000 ,<=12000/mm3 Neu: >= 1,500/ mm3 Plt: >= 100,000/ mm3 Hb: >= 9.0g/dL T-Bil: <= 2.0mg/dL AST,ALT: <= 100IU/L (<= 200IU/L if with Liver metastasis) Cre: <1.5mg/dL Ccr: >= 50mL/min Urinary protein: <= grade1 (+1 or 0.15-1.0g/24h) UGT1A1 genotype: wild type and *6,*28 heterozygote 11) Life expectancy at least 3 months.
Key exclusion criteria	1) Serious complication ( ex. interstitial pneumonitis, pulmonary fibrosis, renal failure, liver failure, poorly-controlled diabetes, poorly-controlled hypertension) 2) Symptomatic or asymptomatic but treated heart disease 3) Active infection.. 4) Pleural effusion, peritoneal fluid 5) History of serious drug hypersensitivity or a history of drug allergy 6) Active other malignancies. 7) History of mental disturbances or cerebrovascular attack, central nervous system disorder 8) Brain metastasis 9) Peptic ulcer, bleeding, intestinal obstruction, intestinal paralysis , gastrointestinal perforation 10) History of gastrointestinal perforation 11) Watery stools or grade 2 or more diarrhea 12) History of thromboembolism, cerebral infarction 13) Hemorrhagic diathesis, coagulation disorder 14) Requiring anti-thrombogenic therapy to prevent thrombosis 15) Requiring steroid drug 16) Receiving flucytosine, atazanavir sulfate 17) Pregnant or lactating woman 18) No birth-control 19) Treatment history of irinotecan 20) History of hemoptysis 21) Contraindication to S-1, CPT-11, bevacizumab 22) High-grade stricture 23) Not appropriate for the study at the physician's assessment
Target sample size	37

Research contact person
Name of lead principal investigator	Yutaka Ogata
Organization	Kurume university medical center
Division name	Surgery
Address	155-1 kokubun-cho, Kurume city, 839-0863, Japan
TEL	0942-22-6111
Email	kscc2@cres-kyushu.or.jp

Public contact
Name of contact person	KSCC
Organization	Clinical Research Support Center Kyushu
Division name	KSCC
Address	3-1-1, Maidashi, Higashi-Ku, Fukuoka, 812-8582 , Japan
TEL	092-631-2920
Homepage URL
Email	kscc2@cres-kyushu.or.jp

Sponsor
Institute	Kyushu Study group of Clinical Cancer
Institute
Department

Funding Source
Organization	Clinical Research Support Center Kyushu
Organization
Division
Category of Funding Organization	Non profit foundation
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

鹿児島県立薩南病院(鹿児島県)、宗像医師会病院（福岡県）、佐世保市立総合病院（長崎県）、健康保険人吉総合病院（熊本県）、国立病院機構別府医療センター（大分県）、済生会福岡総合病院（福岡県）、大牟田市立病院（福岡県）、社会保険田川病院（福岡県）、社会保険久留米第一病院（福岡県）、熊本大学（熊本県）、松山赤十字病院（愛媛県）、国立病院機構南九州病院（鹿児島県）、福岡市民病院（福岡県）、国立病院機構大分医療センター（大分県）、中津市立中津市民病院（大分県）、長崎大学（長崎県）、鹿児島共済会南風病院（鹿児島県）、済生会八幡総合病院（福岡県）、熊本中央病院（熊本県）、高地医療センター（高知県）、春回会 井上病院（長崎県）、大分赤十字病院（大分県）、製鉄記念八幡病院（福岡県）、公立学校共済組合九州中央病院（福岡県）、神戸市立医療センター中央市民病院（兵庫県）、久留米大学医療センター（福岡県）、今給黎総合病院（鹿児島県）、済生会川内病院（鹿児島県）、長崎百合野病院（長崎県）、鹿児島大学（鹿児島県）、宮崎県立日南病院（宮崎県）、健康保険八代総合病院（熊本県）、中頭病院（沖縄県）、久留米大学（福岡県）、九州大学（福岡県）、聖マリア病院（福岡県）、岡山労災病院（岡山県）、豊見城中央病院（沖縄県）、済生会熊本病院(熊本県）、大分県立病院（大分県）、国立病院機構福岡東医療センター（福岡県）、田川市立病院（福岡県）、社会保険仲原病院（福岡県）、県民健康プラザ鹿屋医療センター（鹿児島県）、高野会　高野病院（熊本県）、独立行政法人国立病院機構熊本再春荘病院（熊本県）、熊本市立熊本市民病院（熊本県）

Other administrative information
Date of disclosure of the study information	2011 Year 09 Month 08 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2011 Year 08 Month 04 Day
Anticipated trial start date	2011 Year 08 Month 04 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Published
URL releasing results	http://www.ncbi.nlm.nih.gov/pubmed/26746689
Results
Other related information

Management information
Registered date	2011 Year 09 Month 08 Day
Last modified on	2017 Year 01 Month 13 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007472