UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008377 |
|---|---|
| Receipt number | 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 14:56:51 |
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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
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
takeshin@cc.okayama-u.ac.jp
Sponsor or person
Institute
Department of Gastroenterological Surgery
Okayama University Graduate School of Medicine Dentistry and Pharmaceutical Sciences
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009848
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