UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001963 |
|---|---|
| Receipt number | R000002392 |
| Scientific Title | Phase II clinical trial of the third-line Cetuximab and irinotecan or Cetuximab therapy for patients with KRAS wild type unresectable/recurrent colorectal cancer |
| Date of disclosure of the study information | 2009/05/13 |
| Last modified on | 2009/05/12 23:14:21 |
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Basic information
Public title
Phase II clinical trial of the third-line Cetuximab and irinotecan or Cetuximab therapy for patients with KRAS wild type unresectable/recurrent colorectal cancer
Acronym
CEREB trial
:CEtuximab,REsearch on Biomarker
Scientific Title
Phase II clinical trial of the third-line Cetuximab and irinotecan or Cetuximab therapy for patients with KRAS wild type unresectable/recurrent colorectal cancer
Scientific Title:Acronym
CEREB trial
:CEtuximab,REsearch on Biomarker
Region
| Japan |
Condition
Condition
Colorectal Cancer
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and safety between the combination regimen of Cetuximab puls irinotecan and Cetuximab alone regimen in patients with previously treated KRAS wild type unresectable/recurrent colorectal cancer
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
Adverse events of grade 3/4
Key secondary outcomes
Response Rate, Progression free survival, Overall survival,Time to progression, The incidence of grade 3/4 Skin toxicity,Time to progression of irinotecan combined regimen(A group)
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Chemotherapy(Cetuximab +irinotecan or cetuximab)
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)Unresectable advanced or recurrent colorectal cancer.
2)KRAS wild type
3)Histologically proved adenocarcinoma, mucinous carcinoma, or signet ring cell carcinoma of the colon or rectum. In the recurrent case, histology of the primary site must have been confirmed in the past. Additional histological confirmation of metastatic or recurrent site is not necessary.
4)Age more than 20years and less than 75 years.
5)ECOG performance status of 0,1 or 2.
6)Survival time more than 2 months after registration expect
7)At least one measurable lesion based on the RECIST criterion.
8)Irinotecan and fluoropyrimidine and oxaliplatin resistant or intorerable case
9)No prior anti-EGFR therapyies
10)Required baseline laboratory parameters (within 7 days before registration):
Hb more than 8.0g/dl
WBC more than 3000 and WBC less than 12000/ul
Plt more than 75,000/ul
T-Bil less than 1.5mg/dl
GOT less than 100 IU/l
GPT less than 100 IU/l
Cre less than 1.5mg/dl
11)Required no therapy time from prior therapy to registration
Surgical procedure over 4 weeks before registration
Radiation :4 weeks
Chemotherapy:4 weeks
12)Signed informed consent of the patient for the registration.
Key exclusion criteria
1)active other malignancies within 5 years
2) history of the severe drug hypersensitivity
3)clinically significant infectious disease(body temperature less than 38.0 degrees)
4)severe complications(ileus, bowel obstruction, interstitial lung disease, pulmonary fibrosis, uncontrolled diabetes mellitus, heart failure, renal failure, hepatic failure and so on)
5) Patients who have abnormal findings on ECG and need any treatment (within 4 weeks before the registration.)
6) Moderate/severe pleural effusion or ascites
7) Symptomatic brain metastasis
8)Patient need transfusion because GI bleeding
9) Uncontrolled watery diarrhea.
Watery colostomy output without trouble with patient's daily living is allowed.
10) Pregnant or lactating women, women who are capable of pregnancy or intend to get pregnant, men who don't intend to have protected intercourse.
11) Any other cases who are regarded as inadequate for study enrollment by the investigator.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Ken Kato |
Organization
National Cancer Center Hospital
Division name
Gastrointestinal Oncology Division
Zip code
Address
5-1-1 Tsukiji Chuo-ku Tokyo
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yuriko Ito |
Organization
National Cancer Center Hospital
Division name
Gastrointestinal Oncology Division
Zip code
Address
5-1-1 Tsukiji Chuo-ku Tokyo
TEL
Homepage URL
Sponsor or person
Institute
National Cancer Center Hospital
Institute
Department
Personal name
Funding Source
Organization
Ministry of Health, Labor and Welfare
Organization
Division
Category of Funding Organization
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
| 2009 | Year | 05 | Month | 13 | 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
Date of protocol fixation
| 2008 | Year | 12 | Month | 09 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2010 | Year | 03 | 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
| 2009 | Year | 05 | Month | 12 | Day |
Last modified on
| 2009 | 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=R000002392
