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UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000008377
Receipt No. R000009848
Scientific Title Phase II clinical trial of Cetuximab with Fluorouracil therapy for patients refractory or intolerable to Oxaliplatin and Irinotecan with KRAS wild-type unresectable/recurrent colorectal cancer
Date of disclosure of the study information 2012/07/08
Last modified on 2018/06/25

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Basic information
Public title Phase II clinical trial of Cetuximab with Fluorouracil therapy for patients refractory or intolerable to Oxaliplatin and Irinotecan with KRAS wild-type unresectable/recurrent colorectal cancer
Acronym Phase II clinical trial of Cetuximab with Fluorouracil therapy for patients with KRAS wild-type unresectable/recurrent colorectal cancer
Scientific Title Phase II clinical trial of Cetuximab with Fluorouracil therapy for patients refractory or intolerable to Oxaliplatin and Irinotecan with KRAS wild-type unresectable/recurrent colorectal cancer
Scientific Title:Acronym Phase II clinical trial of Cetuximab with Fluorouracil therapy for patients with KRAS wild-type unresectable/recurrent colorectal cancer
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 efficacy and the safety of Cetuximab with Fluorouracil therapy for patients refractory or intolerable to Oxaliplatin and Irinotecan with KRAS wild-type unresectable/recurrent colorectal cancer.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes Progression-free survival; PFS
Key secondary outcomes Response Rate; RR, Overall survival; OS, Safety

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 (Cetuximab with Fluorouracil therapy)
Cetuximab=400mg/m2 (day1)Cetuximab=250mg/m2/weekly(day 8-)
with
1) l-LV=200mg/m2/bi-week
5-FU/bolus=400mg/m2/bi-week
5-FU/infusional=2,400mg/m2/bi-week (day1-3)
2) LV=75mg/day (*Administration for 4weeks and Drug withdrawal for one week)UFT=300-600mg/day*
3) Capecitabine=2,000mg/m2/day(*Administration for 2weeks and Drug withdrawal for one week)
4) S-1=80-120mg/day (*Administration for 2weeks and Drug withdrawal for one week)
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) Histopathological confirmation of Adenocarcinoma
2) EGFR expression confirmed by immunohistochemistry either in the primary tumor or in metastatic tumor lesion
3) KRAS wild type (in codon 12, 13) confirmed, either in the primary tumor or in metastatic tumor lesion
4) Patients refractory or intolerable to Oxaliplatin and Irinotecan
5) Age of 20 or more years old
6) ECOG performance status of 0 to 2
7) Presence of at least one measurable lesion according to RECIST
8) Sufficient oral intake
9) Sufficient function of important organs
1. WBC:>= 2,000 /mm3
2. Neu: >= 1,500 /mm3
3. Platelet: >= 75,000 /mm3
4. Hemoglobin: >= 8.0 g/dL
5. Sr.bil : <= 2.0 mg/dL
6. AST, ALT: <= upper limits of normal (ULN)x2.5 (patients with liver metastasis; AST, ALT : <= ULNx5.0)
7. Serum creatinine: <= ULNx1.5
10) Expected more than 3 months survival
11) With written informed consent
Key exclusion criteria 1) Synchronous or metachronous (within 5 years) malignancy other than carcinoma in situ
2) Patients with brain metastasis which have symptoms or patients with history of brain metastasis
3) Severe wattery diarrhea
4) Severe infectious disease
5) Severe complications (interstitial lung disease or pulmonary fibrosis, kidney failure, hepatic failure, uncontrolable diabetes, uncontrolable hypertension)
5) History of interstitial lung disease or pulmonary fibrosis
6) Severe carcinomatous ascites, pleural effusion or pericardial cavity effusion
7) Pregnant or lactating women or women of childbearing potential, and no birth-control
8) Patients with history of serious hypersensitivity
9) Patients who received the anti-EGFR antibodies within 3 months
10) Any other cases who are regarded as inadequate for study enrollment by the investigator
Target sample size 45

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Toshiyoshi Fujiwara
Organization Okayama University Graduate School of Medicine Dentistry and Pharmaceutical Sciences
Division name Department of Gastroenterological Surgery
Zip code
Address 2-5-1 Shikata-cho, Okayama City, Okayama 700-8558, Japan
TEL 068-235-7257
Email surgery1@md.okayama-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Takeshi Nagasaka
Organization Okayama University Graduate School of Medicine Dentistry and Pharmaceutical Sciences
Division name Department of Gastroenterological Surgery
Zip code
Address 2-5-1 Shikata-cho, Okayama City, Okayama 700-8558, Japan
TEL 086-235-7257
Homepage URL
Email takeshin@cc.okayama-u.ac.jp

Sponsor
Institute Department of Gastroenterological Surgery
Okayama University Graduate School of Medicine Dentistry and Pharmaceutical Sciences
Institute
Department

Funding Source
Organization Department of Gastroenterological Surgery
Okayama University Graduate School of Medicine Dentistry and Pharmaceutical Sciences
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
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
2012 Year 07 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 Terminated
Date of protocol fixation
2012 Year 07 Month 01 Day
Date of IRB
Anticipated trial start date
2012 Year 07 Month 08 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 07 Month 08 Day
Last modified on
2018 Year 06 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009848

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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