UMIN-CTR Clinical Trial

Public title

Phase II study of bevacizumab and irinotecan plus alternate-day S-1 as second-line therapy in patients with metastatic colorectal cancer.

Acronym

AIRS study

Scientific Title

Phase II study of bevacizumab and irinotecan plus alternate-day S-1 as second-line therapy in patients with metastatic colorectal cancer.

Scientific Title:Acronym

AIRS study

Region

Japan

Condition

Metastatic colorectal cancer.

Classification by specialty

Gastroenterology	Hematology and clinical oncology	Gastrointestinal surgery

Classification by malignancy

Malignancy

Genomic information

NO

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

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

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

Name of lead principal investigator

1st name
Middle name
Last name	Hideyuki Mishima

Organization

Aichi Medical University Hospital

Division name

Cancer Center

Zip code

Address

1-1, Yazagokarimata, Nagakute, Aichi, 480-1195, Japan

TEL

0561-62-3311

Email

hmishima@aichi-med-u.ac.jp

Name of contact person

1st name
Middle name
Last name	Yumi Miyashita

Organization

Epidemiological and Clinical research Information Network (ECRIN)

Division name

ECRIN Data Center

Zip code

Address

1-7-9 Hanenishi, Okazaki, Aichi, JAPAN

TEL

0564-64-7300

Homepage URL

Email

miya@ecrin.or.jp

Institute

Epidemiological and Clinical research Information Network (ECRIN)

Institute

Department

Personal name

Organization

Epidemiological and Clinical research Information Network (ECRIN)

Organization

Division

Category of Funding Organization

Non profit foundation

Nationality of Funding Organization

Japan

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2012

Year

09

Month

19

Day

URL releasing protocol

Publication of results

Published

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

Recruitment status

Completed

Date of protocol fixation

2012

Year

05

Month

01

Day

Date of IRB

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

Other related information

Registered date

2012

Year

09

Month

19

Day

Last modified on

2018

Year

09

Month

20

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010491