UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009318 |
|---|---|
| Receipt number | 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 11:07:43 |
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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
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
hazama@yamaguchi-u.ac.jp
Sponsor or person
Institute
Yamaguchi University
Department of Digestive Surgery and Surgical Oncology
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010945
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