Unique ID issued by UMIN | UMIN000005958 |
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Receipt number | R000007003 |
Scientific Title | A study of panitumumab, oxaliplatin, fluorouracil and l-leucovorine as first-line treatment in patients with KRAS wild-type metastatic colorectal cancer. (PANORAMA study) |
Date of disclosure of the study information | 2011/07/11 |
Last modified on | 2015/08/12 14:35:19 |
A study of panitumumab, oxaliplatin, fluorouracil and l-leucovorine as first-line treatment in patients with KRAS wild-type metastatic colorectal cancer.
(PANORAMA study)
A study of panitumumab, oxaliplatin, fluorouracil and l-leucovorine as first-line treatment in patients with KRAS wild-type metastatic colorectal cancer.
(PANORAMA study)
A study of panitumumab, oxaliplatin, fluorouracil and l-leucovorine as first-line treatment in patients with KRAS wild-type metastatic colorectal cancer.
(PANORAMA study)
A study of panitumumab, oxaliplatin, fluorouracil and l-leucovorine as first-line treatment in patients with KRAS wild-type metastatic colorectal cancer.
(PANORAMA study)
Japan |
KRAS wild-type metastatic colorectal cancer
Surgery in general | Gastrointestinal surgery | Hepato-biliary-pancreatic surgery |
Malignancy
NO
To evaluate the efficacy and safety of panitumumab with FOLFOX as first-line treatment in patients with KRAS wild-type metastatic colorectal cancer in Japan.
Safety,Efficacy
Exploratory
Pragmatic
Phase II
Overall Response Rate
Progression-free survival
Overall Survival
Adverse Effect
Resection rate of metastatic resion
R0 resection rate
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
FOLFOX+Pmab is repeated every 14 days until meeting the withdrawal criteria.
20 | years-old | <= |
Not applicable |
Male and Female
1)Histological confirmation of colorectal cancer.
2)Unresectable relapse or metastatic colorectal cancer.
3) Measurable or evaluable disease (RECIST ver.1.1.)
4)KRAS Wild-type
5)No prior chemotherapy except adjuvant chemotherapy if completed more than 6months (L-OHP base: more than 12months) prior to enrollment.
6) Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2.
7) Age of 20 years or older.
8) Vital organ functions (listed below) are preserved within 2 weeks prior to entry.
i WBC 3,000/mm3 >= and =<12,000/mm3
ii Neurtophils>=1500/mm3
iii Platelets>=100,000/mm3
iv Hemoglobin>=9.0g/dl
v AST and ALT =<upper limit of normal (ULN)*2.5 (=<ULN*5 in case of liver metastasis)
vi Total bilirubin =<upper limit of normal (ULN)*2.0
vii Serum creatinine =<upper limit of normal (ULN)*1.25
9)Written informed consent.
1) Peripheral sensory neuropathy (CTCAEv4.0;>=Grade1).
2) Histroy of the serious hypersensitivity for drugs.
3) Active infection.
4) Complications (Evidence of interstinal lung disease, emphysema, pulmonary fibrosis,paralytic or mechanical bowel obstruction, uncontrolled hypertension,uncontrolled diabetes mellitus,cirrhosis, active cardiovascular disease, or past current history (within 3 months) of myocardial infarction, uncontrolled angina pectoris or arrhythmia.
5) Multiple primary cancer within 5years.
6) Need to drain pleural effusion, ascites or pericardial effusion.
7) Uncontrolled diarrhea.
8) Radiological evidence of brain metastasis.
9) Clinically significant mental or psychological disease.
10) Other conditions not suitable for this study.
42
1st name | |
Middle name | |
Last name | Hiroyuki Kuwano |
Gunma University
Department of general surgical science
3-39-22,syowacho,maebashi-city,Gunma
027-220-8224
hkuwano@med.gunma-u.ac.jp
1st name | |
Middle name | |
Last name | Takayuki Asao and Soichi Tsutsumi |
Gunma University
Department of general surgical science
3-39-22,syowacho,maebashi-city,Gunma
027-220-8224
chuchumi@showa.gunma-u.ac.jp
SCOT:Surgical and Clinical gastrointestinal Oncology Trial Group in north kanto and shinnetsu.
NPO Gunma Cancer Academy
Non profit foundation
NO
群馬大学医学部附属病院
獨協医科大学病院
信州大学医学部附属病院
新潟大学医歯学総合病院
自治医科大学付属さいたま医療センター
他
2011 | Year | 07 | Month | 11 | Day |
Unpublished
No longer recruiting
2011 | Year | 06 | Month | 18 | Day |
2011 | Year | 07 | Month | 01 | Day |
2016 | Year | 06 | Month | 01 | Day |
2011 | Year | 07 | Month | 11 | Day |
2015 | Year | 08 | Month | 12 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007003
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