UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006793 |
|---|---|
| Receipt number | R000008043 |
| Scientific Title | Multicenter phase II study of combination chemotherapy with IRIS and Cetuximab as second line therapy in patient with colorectal cancer |
| Date of disclosure of the study information | 2011/12/01 |
| Last modified on | 2012/07/23 18:51:13 |
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Basic information
Public title
Multicenter phase II study of combination chemotherapy with IRIS and Cetuximab as second line therapy in patient with colorectal cancer
Acronym
Multicenter phase II study of combination chemotherapy with IRIS and Cetuximab as second line therapy in patient with colorectal cancer
Scientific Title
Multicenter phase II study of combination chemotherapy with IRIS and Cetuximab as second line therapy in patient with colorectal cancer
Scientific Title:Acronym
Multicenter phase II study of combination chemotherapy with IRIS and Cetuximab as second line therapy in patient with colorectal cancer
Region
| Japan |
Condition
Condition
colorectal cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To evaluate efficacy and safety of combination therapy with IRIS and Cetuximab in L-OHP failure patients with colorectal cancer.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Phase II
Assessment
Primary outcomes
response rate
Key secondary outcomes
progression free survival
overall survival
disease control rate
re-resection rate
adverse event
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
S-1 : day1-14 80mg/m2.
CPT-11 : day1 150mg/m2
Cetuximab : day1,8,15 400mg/m2 (1st time) , 250mg/m2 (2nd time or another)
to be repeated every 3 weeks
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Histologically confirmed colorectal cancer
2) Unresectable advanced/recurrent colorectal cancer
3) Age between 20 to 80 years
4) ECOG performance status 0-1
5) Presence of measurable lesion (RECIST)
6) Prior chemotherapy involving L-OHP
7) No prior chemotherapy involving CPT-11 or Cetuximab
8) Sufficient organ functions
9) The case can eat
10) Written informed consent
Key exclusion criteria
1) History of severe allergy
2) Simultaneous or metachronous double cancers
3) active infectious disease,
4) Severe comorbidity
5) Massive pleural effusion or ascites
6) Wattery diarrhea
7) Paralytic or mechanical bowel obstruction
8) Symptomatic brain metastasis
9) Patients who is receiving Fluorocytosine or Atazanavir Sulfate
10) Pregnant or lactating women or women of childbearing potential.
11) Amalgamation of mental disease or psychotic manifestation
12) Patients who are inadequate by investigator's decision.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hideyuki Suzuki |
Organization
Nippon Medical School Musashikosugi Hospital
Division name
Institute of Gastroenterology
Zip code
Address
1-396 Kosugicho, Nakahara-ku, Kawasaki-city, 211-8533, Japan
TEL
044-733-5181
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hideyuki Suzuki |
Organization
Nippon Medical School Musashikosugi Hospital
Division name
Institute of Gastroenterology
Zip code
Address
1-396 Kosugicho, Nakahara-ku, Kawasaki-city, 211-8533, Japan
TEL
044-733-5181
Homepage URL
Sponsor or person
Institute
Nippon Medical School Musashikosugi Hospital
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Nippon Medical School Hospital
Nippon Medical School Tama Nagayama Hospital
Nippon Medical School Chiba Hokusoh Hospital
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
日本医科大学武蔵小杉病院（神奈川県）
日本医科大学付属病院（東京都）
日本医科大学多摩永山病院（東京都）
日本医科大学千葉北総病院（千葉県）
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 12 | 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
Enrolling by invitation
Date of protocol fixation
| 2011 | Year | 11 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2011 | Year | 11 | Month | 30 | Day |
Last modified on
| 2012 | Year | 07 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008043
