Unique ID issued by UMIN | UMIN000008542 |
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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 |
study of medical treatment reactivity by the chemokine receptor (CXCR4)as 1st line treatment in patients with metastatic colorectal cancer
CREPAS
study of medical treatment reactivity by the chemokine receptor (CXCR4)as 1st line treatment in patients with metastatic colorectal cancer
CREPAS
Japan |
Colorectal Cancer
Gastroenterology |
Malignancy
NO
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
Safety,Efficacy
Exploratory
Pragmatic
Phase II
Progression-free survival
Safety profile,
Overall survival,
Time-to-treatment-failure ,
Overall Response Rate
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
Active
YES
4
Treatment
Medicine |
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
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
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
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
20 | years-old | <= |
80 | years-old | >= |
Male and Female
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
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
160
1st name | |
Middle name | |
Last name | Satoshi Matsusaka |
The Cancer Institute Hospital of JFCR
Department of Gastroenterology
3-8-31, Ariake, Koto, Tokyo 135-8550
03-3520-0111
satoshi.matsusaka@jfcr.or.jp
1st name | |
Middle name | |
Last name | Satoshi Matsusaka |
The Cancer Institute Hospital of JFCR
Department of Gastroenterology
3-8-31, Ariake, Koto, Tokyo 135-8550
03-3520-0111
satoshi.matsusaka@jfcr.or.jp
The Cancer Institute Hospital of JFCR
None
Other
NO
2012 | Year | 07 | Month | 28 | Day |
Unpublished
Enrolling by invitation
2012 | Year | 04 | Month | 04 | Day |
2012 | Year | 07 | Month | 28 | Day |
2012 | Year | 07 | Month | 26 | Day |
2017 | Year | 07 | Month | 31 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010030
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