UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Phase II study of bevacizumab and irinotecan plus alternate-day S-1 as second-line therapy in patients with metastatic colorectal cancer.
Title of the study (Brief title)	AIRS study
Region	Japan

Condition
Condition	Metastatic colorectal cancer.
Classification by specialty	Gastroenterology Hematology and clinical oncology Gastrointestinal surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the efficacy and safety of alternate-day S-1 with bevacizumab and irinotecan as second-line treatment in patients with metastatic colorectal cancer previously treated with 5-FU and oxaliplatin +/- bevacizumab
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Phase II

Assessment
Primary outcomes	Incidence of grade 3 or 4 diarrhea
Key secondary outcomes	Response rate, Disease-cintrol rate, Overall survival, Progression-free survival, Time to treatment failure, Treatment completion rate, Safety

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	Alternate-day S-1 (80mg/m2; day 2,4,6...14) combined with irinotecan (150mg/m2; day 1) and bevacizumab (5.0 mg/kg; day 1)
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) Histologically confirmed colorectal cancer (adenocarcinoma) 2) Unresectabler metastatic colorectal cancer 3) Age, 20 years old and above 4) ECOG performance status of 0-1 5) One prior first line chemotherapy consisting of fluoropyrimidine (except TS-1) and oxaliplatin with or without bevacizumab 6) Adequate organ function within 14 days before registration a)WBC=>3000/mm3 b)Neutrophil=>1500/mm3 c)Platelet count=>100000/mm3 d)Hemoglobin=>9.0 g/dL e)AST ALT <= 100 IU/L (Liver Met;AST ALT<= 200 IU/L ) f)Total bilirubin <= 1.5 mg/dL g)Creatinine clearance => 40 mL/min h)Urine protein <=1+ PT-INR <=1+ 7) Able to receive oral treatment 8) Written informed consent
Key exclusion criteria	1)History of serious drug hypersensitivity 2)Active infections 3) Serious complications (interstitial pneumonitis, pulmonary fibrosis, renal failure, liver dysfunction, poorly controlled DM, poorly controlled hypertension) 4) Distinctly abnormal ECG or cardiovascular disease (heart failure, myocardial infarction, angina) 5) Massive pleural effusion or ascites 6) Ongoing treatment with Flucytosine, Phenytoin or Warfarin potassium 7) Synchronous or metachronous malignancy except carcinoma in situ 8) Prior radiotherapy 9) Diarrhea 10) Active hepatitis type HBs positive 11) History of thromboembolism, brain infarction, pulmonary infarction and interstitial pneumonitis 12) GI perforation or hemorrhage 13) Peritoneal metastasis 14) Brain metastasis 15)Pregnant or possibly pregnant women 16) Men who want get partner pregnant. 17) Other conditions not suitable for this study
Target sample size	40

Research contact person
Name of lead principal investigator	Hideyuki Mishima
Organization	Aichi Medical University Hospital
Division name	Cancer Center
Address	1-1, Yazagokarimata, Nagakute, Aichi, 480-1195, Japan
TEL	0561-62-3311
Email	hmishima@aichi-med-u.ac.jp

Public contact
Name of contact person	Yumi Miyashita
Organization	Epidemiological and Clinical research Information Network (ECRIN)
Division name	ECRIN Data Center
Address	1-7-9 Hanenishi, Okazaki, Aichi, JAPAN
TEL	0564-64-7300
Homepage URL
Email	miya@ecrin.or.jp

Sponsor
Institute	Epidemiological and Clinical research Information Network (ECRIN)
Institute
Department

Funding Source
Organization	Epidemiological and Clinical research Information Network (ECRIN)
Organization
Division
Category of Funding Organization	Non profit foundation
Nationality of Funding Organization	Japan

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

Other administrative information
Date of disclosure of the study information	2012 Year 09 Month 19 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2012 Year 05 Month 01 Day
Anticipated trial start date	2012 Year 06 Month 01 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
Results
Other related information

Management information
Registered date	2012 Year 09 Month 19 Day
Last modified on	2018 Year 09 Month 20 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010491