UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000008947
Receipt number R000010491
Scientific Title Phase II study of bevacizumab and irinotecan plus alternate-day S-1 as second-line therapy in patients with metastatic colorectal cancer.
Date of disclosure of the study information 2012/09/19
Last modified on 2018/09/20 08:27:44

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Basic information

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

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

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


Public contact

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


Sponsor or person

Institute

Epidemiological and Clinical research Information Network (ECRIN)

Institute

Department

Personal name



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)



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

2012 Year 09 Month 19 Day


Related information

URL releasing protocol


Publication of results

Published


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

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

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

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name