UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010791 |
|---|---|
| Receipt number | R000012440 |
| Scientific Title | Phase II study of Cetuximab with mFOLFOX6 treatment in patients with previously untreated Rectal cancer |
| Date of disclosure of the study information | 2013/05/23 |
| Last modified on | 2014/05/23 16:52:56 |
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Basic information
Public title
Phase II study of Cetuximab with mFOLFOX6 treatment in patients with previously untreated Rectal cancer
Acronym
Phase II study of Cetuximab with mFOLFOX6 treatment in patients with previously untreated Rectal cancer (CR study in SHIGA)
Scientific Title
Phase II study of Cetuximab with mFOLFOX6 treatment in patients with previously untreated Rectal cancer
Scientific Title:Acronym
Phase II study of Cetuximab with mFOLFOX6 treatment in patients with previously untreated Rectal cancer (CR study in SHIGA)
Region
| Japan |
Condition
Condition
Rectal Cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of the effectiveness and safety of the cetuximab+mFOLFOX6 combination therapy as the primary treatment for KRAS wildtype advanced rectal cancer
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
Response Rate
Key secondary outcomes
Adverse effect (AE)
Progression free survival (PFS)
Disease control rate (DCR)
R0 resection rate
Rate of surgery
Time to Surgery (TTS)
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1) Histologically confirmed colorectal cancer
(2) Previously receive no chemotherapy for rectal cancer
(3) KRAS wild-type
(4) age 20-80 years patients
(5) ECOG performance status 0 or 1
(6) Patients with confirmed target lesion
(7) Patients have enough organ function for study treatment
WBC 3,000/mm3-12,000/mm3
Neutrophils>=1,500/mm3
Platelets>=100,000/mm3
Hemoglobin>=9.0g/dL
Total bilirubin<=1.5mg/dL
AST and ALT<=100 IU/L
Creatinine<=1.2mg/dL
Creatinine Clearance>=60mL/min
(8) Life expectancy of more than 3months
(9) Written informed consent from patients themselves
Key exclusion criteria
(1) History of serious drug hypersensitivity
(2) Women who are pregnant,or wish to become pregnant or men who expect babies
(3) Severe infectious disease (38degrees or higher)
(4) Serious complications
(5) Remarkably abnormal ECG,Clinically significant heart disease
(6) Gastrointestinal ulceration or bleeding
(7) Serious watery diarrhea
(8) Uncontrolable pleural effusion or ascites requiring treatment
(9) Cases with brain metastases or cases to doubt metastasis to brain from clinical manifestations
(10) Current or previous (within the last 6months) history of GI perforation
(11) Previous history of thrombosis,cerebra infarction,pulmonary infarction,hemoptysis (more than 2.5ml) and interstitial pneumonia
(12) Cases were operated within 28days before entry (Except for inserting central venous catheters and reservoir)
(13) Evidence of congenital bleeding diathesis or coagulopathy
(14) Ongoing treatment with anticoagulant
(15) Cases have active double cancer (disease free period is within five years)
(16) Continuous systemic administration of corticosteroids
(17) Patients judged inapproprite for this study by physicians
Target sample size
25
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Eiji Mekata |
Organization
Shiga University of Medical Science
Division name
Department of surgery
Zip code
Address
Seta Tsukinowa-cho,Otsu-city,Shiga,Japan
TEL
077-548-2238
hqchemo@belle.shiga-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | EIJI Mekata |
Organization
Shiga University of Medical Science
Division name
Department of surgery
Zip code
Address
Seta Tsukinowa-cho,Otsu-city,Shiga,Japan
TEL
077-548-2238
Homepage URL
hqchemo@belle.shiga-med.ac.jp
Sponsor or person
Institute
NPO FMPC (Future Medicine Promoting Consortium)
Institute
Department
Personal name
Funding Source
Organization
NPO FMPC (Future Medicine Promoting Consortium)
Organization
Division
Category of Funding Organization
Other
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
| 2013 | Year | 05 | Month | 23 | 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
Open public recruiting
Date of protocol fixation
| 2012 | Year | 12 | Month | 25 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 05 | Month | 29 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
observational study
Management information
Registered date
| 2013 | Year | 05 | Month | 23 | Day |
Last modified on
| 2014 | Year | 05 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012440
