UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003483 |
|---|---|
| Receipt number | R000004216 |
| Scientific Title | Phase II study of biweekly cetuximab and irinotecan for unresectable advanced/recurrent colorectal cancer. Phoenix study |
| Date of disclosure of the study information | 2010/04/14 |
| Last modified on | 2010/05/11 01:29:33 |
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Basic information
Public title
Phase II study of biweekly cetuximab and irinotecan for unresectable advanced/recurrent colorectal cancer.
Phoenix study
Acronym
Phase II study of biweekly cetuximab and irinotecan for unresectable advanced/recurrent colorectal cancer.
Phoenix study
Scientific Title
Phase II study of biweekly cetuximab and irinotecan for unresectable advanced/recurrent colorectal cancer.
Phoenix study
Scientific Title:Acronym
Phase II study of biweekly cetuximab and irinotecan for unresectable advanced/recurrent colorectal cancer.
Phoenix study
Region
| Japan |
Condition
Condition
colorectal cancer
Classification by specialty
| Gastroenterology | Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the safety and efficacy of biweekly cetuximab and irinotecan for unresectable advanced/recurrent colorectal cancer
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Phase II
Assessment
Primary outcomes
response rate
Key secondary outcomes
Disease control rate
Compliance
Progression-free survival
Overall survival
Adverse events
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
Cetuximab 500 mg/m2/biweekly
CPT-11 150 mg/m2/biweekly
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.pathologically diagnosed colorectal cancer.
2.EGFR positive(without K-ras mutation)
3.ECOG PS0-2.
4.target lesion(RECIST 1.0)
5.previously treated within 2 regimens and
wihtout cetuximab. at least 2 week rest.
6.3 months or longer expected survival
7.age over 20 years old.
8.adequate organ function.
9.written IC.
Key exclusion criteria
1.severe heart disease.
2.severe liver disease.
3.severe lung disease.
4.active gastrointestinal bleeding.
5.severe mental disease.
6.severe diabetes/.
7.ileus.
8.active infectious disease.
9.other active cancer.
10.cerebral metastasis.
11.icterus
12.severe diarrhea.
13.severe allergic reaction for drugs
14.massive ascites, plerural effusion.
15.under treatment with atazanavir
16.a pregnant woman, a woman in breast-feeding, a man who expects his baby.
17.an inappropriate case judged by docter in charge.
Target sample size
38
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | SATO Takeo, SASAKI Tohru |
Organization
Kitasato University East Hospital
Division name
Department of gastroenterological surgery, Department of gastroenterology
Zip code
Address
Asamizoda2-1-1, Sagamihara, Kanagawa
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Kitasato University East Hospital
Division name
Department of gastroenterological surgery, Department of gastroenterology
Zip code
Address
TEL
Homepage URL
tohrus@kitasato-u.ac.jp
Sponsor or person
Institute
Kitasato University East Hospital
Department of gastroenterological surgery, Department of gastroenterology
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Kitasato University 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
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 04 | Month | 14 | 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
| 2009 | Year | 08 | Month | 06 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 12 | 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
| 2010 | Year | 04 | Month | 13 | Day |
Last modified on
| 2010 | Year | 05 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004216
