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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000009318
Receipt No. R000010945
Scientific Title A Phase II trial of irinotecan / S-1 (IRIS) + alfa (Panitumumab/Bevacizumab) as 2nd line chemotherapy for metastatic colorectal cancer (mCRC) A multicenter phase II trial of TS1 + Irinotecan (IRIS) + Bevacizumab as second line treatment in patients with KRAS mutant type unresectable advanced colorectal cancer (mCRC).
Date of disclosure of the study information 2012/11/12
Last modified on 2015/05/12

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Basic information
Public title A Phase II trial of irinotecan / S-1 (IRIS) + alfa (Panitumumab/Bevacizumab) as 2nd line chemotherapy for metastatic colorectal cancer (mCRC)
A multicenter phase II trial of TS1 + Irinotecan (IRIS) + Bevacizumab as second line treatment in patients with KRAS mutant type unresectable advanced colorectal cancer (mCRC).
Acronym IRIS-PB trial -Part B-
Scientific Title A Phase II trial of irinotecan / S-1 (IRIS) + alfa (Panitumumab/Bevacizumab) as 2nd line chemotherapy for metastatic colorectal cancer (mCRC)
A multicenter phase II trial of TS1 + Irinotecan (IRIS) + Bevacizumab as second line treatment in patients with KRAS mutant type unresectable advanced colorectal cancer (mCRC).
Scientific Title:Acronym IRIS-PB trial -Part B-
Region
Japan

Condition
Condition metastatic colorectal cancer
Classification by specialty
Gastroenterology Hematology and clinical oncology Surgery in general
Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 Trial of irinotecan + TS-1 (IRIS)+ Bevacizumab as 2nd line chemotherapy for metastatic colorectal cancer (mCRC)
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes PFS
Key secondary outcomes OS, TTF, RR, DCR, Safety, Dose-Intensity

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 Trial of irinotecan / TS-1 (IRIS) + Bevacizumab as 2nd line chemotherapy for metastatic colorectal cancer (mCRC)
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) Histopathologically confirmed colorectal cancer (The primary tumor of an appendix, and an anal canal and the anus is excluded) 2) Unresectable progress recurrence colon cancer 3) Metastatic colorectal cancer which has prior therapy of Oxaliplatin based chemotherapy. But, if it is the recurrence at less than 180 Days after the end of chemotherapy which contains LOHP as a postoperative adjuvant chemotherapy is enforced, it is considered as the object of the examination 4) No prior chemotherapy of CPT11 5) KRAS mutant type 6) The presence of evaluable disease based on the recist criterion. (within 30 days before registration) 7) Adequate organ functions (within 7 days before registration) Leu>3000/mm3, <12000/mm3, Neu>1500 /mm3, Plt>100000 /mm3, Hemoglobin>9.0 g/dL, ALT<ULNx2.5, AST<ULNx2.5, Total.bil<ULNx1.5, Ccr or eGFR>60 ml/min, 8) Age>20, 9)Performance Status (ECOG) 0 to 1, 10) Oral intake possible, 11) Expected more than 3 months survival, 12) With written informed consent
Key exclusion criteria 1)Presence of active multiple primaries.
Active multiple primaries is simultaneous or metachronous with disease-free interval of 5 years or more. But, carcinoma in situ and skin cancer which are judged to be recovery by medical treatment are excluded.
2)Massive pleural effusion or ascites that required drainage
3)Symptomatic brain meta
4)Severe psychiatric disease or psychiatric symptoms
5)Severe complications
6)Undertook radiation therapy for abdominal lesions
7)History of serious drug hypersensitivity or a history of drug allergy
8)Pregnant or lactating woman
9)Requiring steroid drug
10)Receiving flucytosine, atazanavir sulfate
11)Uncontrollable diarrhea 12)Uncontrollable peptic ulcer
13)High-grade peritoneal metastasis and stricture
14)History of the perforation of the digestive tract within 6 months before registration
15)History of the thromboembolism, brain infarction, lung infarction, brain infarction or pneumonitis
16)Operation within 28 days
17)Congenital bleeding predisponency or abnormality of hemostasis
18)Patients have anticoagulant agent
19)Not appropriate for the study at the physician's assessment
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shoichi Hazama
Organization Yamaguchi University
Division name Department of Digestive Surgery and Surgical Oncology
Zip code
Address 1-1-1 Minami-Kogushi, Ube, Yamaguchi, 755-8505, Japan
TEL +81-836-22-2264
Email hazama@yamaguchi-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Shoichi Hazama
Organization YAMAGUCHI UNIVERSITY GRADUATE SCHOOL OF MEDICINE
Division name Department of Digestive Surgery and Surgical Oncology
Zip code
Address 1-1-1 Minamikogushi , Ube, 755-8505, Japan
TEL 81-836-22-2264
Homepage URL
Email hazama@yamaguchi-u.ac.jp

Sponsor
Institute Yamaguchi University
Department of Digestive Surgery and Surgical Oncology
Institute
Department

Funding Source
Organization Yamaguchi University
Department of Digestive Surgery and Surgical Oncology
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
2012 Year 11 Month 12 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 Terminated
Date of protocol fixation
2012 Year 04 Month 19 Day
Date of IRB
Anticipated trial start date
2012 Year 04 Month 25 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 11 Month 12 Day
Last modified on
2015 Year 05 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010945

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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