UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008542 |
|---|---|
| Receipt number | R000010030 |
| Scientific Title | study of medical treatment reactivity by the chemokine receptor (CXCR4)as 1st line treatment in patients with metastatic colorectal cancer |
| Date of disclosure of the study information | 2012/07/28 |
| Last modified on | 2017/07/31 14:02:06 |
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Basic information
Public title
study of medical treatment reactivity by the chemokine receptor (CXCR4)as 1st line treatment in patients with metastatic colorectal cancer
Acronym
CREPAS
Scientific Title
study of medical treatment reactivity by the chemokine receptor (CXCR4)as 1st line treatment in patients with metastatic colorectal cancer
Scientific Title:Acronym
CREPAS
Region
| Japan |
Condition
Condition
Colorectal Cancer
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
A study whether a combination therapy of FOLFOX and Panitumumab will extend PFS more than the combination therapy of FOLFOX and Bevacizumab in KRAS wild-type metastatic colorectal cancer patients measured with more than 20% in CXCR4+CEC. In addition, those measured less than 20% in CXCR4+CEC will also be included in the study
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
Key secondary outcomes
Safety profile,
Overall survival,
Time-to-treatment-failure ,
Overall Response Rate
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
4
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
CXCR4-CEC>=20
mFOLFOX6,Bevacizumab
L-OHP:85mg/m2
5-FU(bolus):400mg/m2
l-LV:200mg/m2
5-FU(infusion):2,400mg/m2
Bevacizumab:5mg/m2
Interventions/Control_2
CXCR4-CEC>=20
mFOLFOX6,Panitumumab
L-OHP:85mg/m2
5-FU(bolus):400mg/m2
l-LV:200mg/m2
5-FU(infusion):2,400mg/m2
Panitumumab :6mg/m2
Interventions/Control_3
CXCR4-CEC<20
mFOLFOX6,Bevacizumab
L-OHP:85mg/m2
5-FU(bolus):400mg/m2
l-LV:200mg/m2
5-FU(infusion):2,400mg/m2
Bevacizumab:5mg/m2
Interventions/Control_4
CXCR4-CEC<20
mFOLFOX6,Panitumumab
L-OHP:85mg/m2
5-FU(bolus):400mg/m2
l-LV:200mg/m2
5-FU(infusion):2,400mg/m2
Panitumumab :6mg/m2
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 proved Colon cancer or rectalcancer
2) KRAS wild-type
3) measurable lesion
4) Age:20 to 80years
5) ECOG performance status of 0, 1 or 2
6) Expected survival >=3 months
7)Signed informed consent of the patient for registration
8) Adequate organ functions as listed below (at <=14 days prior to enrollment)
WBC:4,000/mm3 to 12,000/mm3
Neutrophl: 2,000/mm3 to 6,000/mm3
Plt: >=100,000/mm3
Hb: >=9.0g/dL
Total bilirubin <= upper limit of normal (ULN)*1.5
AST ,ALT and ALP <= upper limit of normal (ULN)*2.5
Serum creatinine <=upper limit of normal (ULN)*1.5
Key exclusion criteria
1)Prior severe drug allergy
2) Be Administered or less than 7 days finished administration Compound Drug of tegafur,gimeracil and oteracil potassium
3) The anti-EGFR antibody (Panitumumab or Cetuximab) has been prescribed for the patient until now.
4) A patient with myelosuppression
5) Patients with large quantity of pleural effusion or ascites
6) Active infection
7) A patient with intestinal tract paralysis and ileus
8) A patient with jaundice
9) A patient with a critical renal damage or a liver damage
10) Under Flucytosine medication
11) severe pulmonary dysfunction
12)K-RAS mutation
13) Concerning pregnancy
14) Complication of cerebrovascular disease or symptoms within 1 years
15) Surgery, biopsy specimen with section or sutures within the past 4 weeks. Fine needle aspiration biopsy within 1 week
16) Administering antithrombotic drug within 10 days
17) Need to administrate or having anti-platelets therapy (including Methotrexate aspirin and NSAIDS
18) Diathesis of bleeding (history of hemoptysis, including cavitation and/or necrosis in lung metastasis confirmed by imaging), coagulopathy or abnormality of coagulation factor as INR>=1.5
19) active peptic ulcer
20) History of gastrointestinal perforation within 1 year
21) Traumatic fracture of unrecovery
22) Nephropathy that requires medication or transfusion or urine protein over +2 within 2 weeks examination
23) Uncontrollable hypertension
24) Uncontrollable diabetes mellitus
25) Patient with symptomatic cardiovascular disease or asymptomatic disease but have been treated (>=Grade 2 according to NCI-CTCAE ver.4). History of myocardial
26) History of hypersensitivity against fluorouracil or platinum agents.
27) History of organ transplantation
28)any other cases who are regarded as unsuitable for enrollment in the study by the investigator
Target sample size
160
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Satoshi Matsusaka |
Organization
The Cancer Institute Hospital of JFCR
Division name
Department of Gastroenterology
Zip code
Address
3-8-31, Ariake, Koto, Tokyo 135-8550
TEL
03-3520-0111
satoshi.matsusaka@jfcr.or.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Satoshi Matsusaka |
Organization
The Cancer Institute Hospital of JFCR
Division name
Department of Gastroenterology
Zip code
Address
3-8-31, Ariake, Koto, Tokyo 135-8550
TEL
03-3520-0111
Homepage URL
satoshi.matsusaka@jfcr.or.jp
Sponsor or person
Institute
The Cancer Institute Hospital of JFCR
Institute
Department
Personal name
Funding Source
Organization
None
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
| 2012 | Year | 07 | Month | 28 | 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
Enrolling by invitation
Date of protocol fixation
| 2012 | Year | 04 | Month | 04 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 07 | Month | 28 | 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 | 26 | Day |
Last modified on
| 2017 | Year | 07 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010030
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
