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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000004507
Receipt No. R000005388
Scientific Title Pharmacogenomic analysis for 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 2010/11/08
Last modified on 2018/10/31

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Basic information
Public title Pharmacogenomic analysis for 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 Pharmacogenomic analysis for 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 YES

Objectives
Narrative objectives1 To search the factors which influence the efficacy and safety of the combination regimen of Cetuximab puls irinotecan and Docetaxel alone regimen in patients with previously treated KRAS wild type unresectable/recurrent colorectal cancer
Basic objectives2 PK,PD
Basic objectives -Others
Trial characteristics_1 Exploratory
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.
16) Pregnant or lactating women, women who are capable of pregnancy or intend to get pregnant, men who don't intend to have protected intercourse.
17) Any other cases who are regarded as inadequate for study enrollment by the investigator.
Target sample size 60

Research contact person
Last name of lead principal investigator
1st name
Middle name
Last name Ken Kato KK
Organization National Cancer Center Hospital
Division name Gastrointestinal Oncology Division
Zip code
Address 5-1-1, Tsukiji, Chuo-ku, Tokyo
TEL 0335422511
Email NCC_IRBoffice@ml.res.ncc.go.jp

Public contact
1st name of contact person
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
TEL 03-3542-2511
Homepage URL
Email kenkato@ncc.go.jp

Sponsor
Institute National Cancer Center Hospital
Institute
Department

Funding Source
Organization Ministry of Health, Labor and Welfare
Organization
Division
Category of Funding Organization Japanese Governmental office
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
2010 Year 11 Month 08 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 Completed
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
2013 Year 03 Month 01 Day
Date of closure to data entry
2013 Year 03 Month 01 Day
Date trial data considered complete
2013 Year 05 Month 01 Day
Date analysis concluded
2013 Year 05 Month 01 Day

Other
Other related information

Management information
Registered date
2010 Year 11 Month 05 Day
Last modified on
2018 Year 10 Month 31 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005388

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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