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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001060
Receipt No. R000001283
Scientific Title Phase II Study of FOLFIRI Plus Bevacizumab (AVASIRI) in Patients as Second Line Chemotherapy of Unresectable Colorectal Cancer
Date of disclosure of the study information 2008/03/01
Last modified on 2010/09/03

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Basic information
Public title Phase II Study of FOLFIRI Plus Bevacizumab (AVASIRI) in Patients as Second Line Chemotherapy of Unresectable Colorectal Cancer


Acronym AVASIRI trial
Scientific Title Phase II Study of FOLFIRI Plus Bevacizumab (AVASIRI) in Patients as Second Line Chemotherapy of Unresectable Colorectal Cancer


Scientific Title:Acronym AVASIRI trial
Region
Japan

Condition
Condition Colorectal Cancer
Classification by specialty
Gastroenterology
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 The purpose of this study is to determine confirmed objective response rate to combination therapy with bevacizumab plus FOLFIRI on best overall objective response rate by RECIST and safety in the second-line treatment of patients with metastatic colorectal cancer.
Basic objectives2 Pharmacokinetics
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes Assessment of overall response rate (ORR; complete response [CR] + partial response [PR]).
Key secondary outcomes Assessment of overall survival (OS), progression free survival. time to treatment failure and 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 5-FU, CPT-11, Bevacizumab
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) Inoperable, locally advanced and/or metastatic colorectal cancer
2) Histologically confirmed adenocarcinoma, mucinous adenocarcinoma or signet-ring cell carcinoma
3) Age 20 to 75
4) Performance status 0-2(ECOG)
5) Measurable disease or non-measurable but assessable disease according to the Response Evaluation Criteria in Solid Tumors (RECIST)
6) Have prior chemotherapy as first line treatment
7) No prior CPT-11 and bevacizumab administration
8) Urine dipstick for proteinuria should be<2+
9) Adequate function of major organs as defined below:
Hb >8.0g/dl
WBC 3,000-12,000/ul
Platelet >100,000/ul
Bilirubin <1.5 mg/dL
GOT and GPT <100 IU/L
Creatinine <1.5 mg/dL
10) Voluntary written informed consent
Key exclusion criteria 1) Active double cancer
2) Serious drug hypersensitivity or a history of drug allergy
3) Active infections
4) Serious complications (e.g., intestinal tract paralysis, ileus, pulmonary fibrosis, interstitial pneumonitis, heart failure, renal failure or hepatic failure.)
5) Uncontrolled hypertension
6) Abnormal EKG
7) Severe ascites
8) Metastasis to the CNS
9) History or evidence of inherited bleeding diathesis
10) Coagulopathy with the risk of bleeding
11) Patient with a past history of thrombosis, cerebral infarction, myocardial infarction, or pulmonary embolism
12) HBs Ab positive, HCV At positive
13) Uncontrolled watery diarrhea
14) Major surgical procedure within 4 weeks
15) Pregnant women, possibly pregnant women, women wishing to become pregnant, and nursing mothers. Men who are currently attempting to conceive children.
16) Judged ineligible for participation in the study by the investigator for safety reasons.

Target sample size 35

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yasuhide Yamada
Organization National Cancer Center Hospital
Division name Gastrointestinal Oncology Division
Zip code
Address 5-1-1 Tsukiji, Chuo-ku, Tokyo
TEL 03-3542-2511
Email

Public contact
Name of contact person
1st name
Middle name
Last name Yoshinori Hirashima
Organization National Cancer Center Hospital
Division name Gastrointestinal Oncology Division
Zip code
Address 5-1-1 Tsukiji, Chuo-ku, Tokyo
TEL 03-3542-2511
Homepage URL
Email aoitonoria@yahoo.co.jp

Sponsor
Institute National Cancer Center Hospital, Gastrointestinal Oncology Division
Institute
Department

Funding Source
Organization National Cancer Center Hospital, Gastrointestinal Oncology Division
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

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
2008 Year 03 Month 01 Day

Related information
URL releasing protocol
Publication of results Unpublished

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
2007 Year 10 Month 22 Day
Date of IRB
Anticipated trial start date
2008 Year 02 Month 01 Day
Last follow-up date
2009 Year 12 Month 01 Day
Date of closure to data entry
2009 Year 12 Month 01 Day
Date trial data considered complete
2009 Year 12 Month 01 Day
Date analysis concluded
2010 Year 03 Month 01 Day

Other
Other related information

Management information
Registered date
2008 Year 03 Month 01 Day
Last modified on
2010 Year 09 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001283

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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