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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000005958
Receipt No. 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

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Basic information
Public 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)
Acronym A study of panitumumab, oxaliplatin, fluorouracil and l-leucovorine as first-line treatment in patients with KRAS wild-type metastatic colorectal cancer.
(PANORAMA study)
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)
Scientific Title:Acronym A study of panitumumab, oxaliplatin, fluorouracil and l-leucovorine as first-line treatment in patients with KRAS wild-type metastatic colorectal cancer.
(PANORAMA study)
Region
Japan

Condition
Condition KRAS wild-type metastatic colorectal cancer
Classification by specialty
Surgery in general Gastrointestinal surgery Hepato-biliary-pancreatic surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 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.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes Overall Response Rate
Key secondary outcomes Progression-free survival
Overall Survival
Adverse Effect
Resection rate of metastatic resion
R0 resection rate

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 FOLFOX+Pmab is repeated every 14 days until meeting the withdrawal criteria.
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)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.
Key exclusion criteria 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.
Target sample size 42

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroyuki Kuwano
Organization Gunma University
Division name Department of general surgical science
Zip code
Address 3-39-22,syowacho,maebashi-city,Gunma
TEL 027-220-8224
Email hkuwano@med.gunma-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Takayuki Asao and Soichi Tsutsumi
Organization Gunma University
Division name Department of general surgical science
Zip code
Address 3-39-22,syowacho,maebashi-city,Gunma
TEL 027-220-8224
Homepage URL
Email chuchumi@showa.gunma-u.ac.jp

Sponsor
Institute SCOT:Surgical and Clinical gastrointestinal Oncology Trial Group in north kanto and shinnetsu.
Institute
Department

Funding Source
Organization NPO Gunma Cancer Academy
Organization
Division
Category of Funding Organization Non profit foundation
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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 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


Other administrative information
Date of disclosure of the study information
2011 Year 07 Month 11 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 No longer recruiting
Date of protocol fixation
2011 Year 06 Month 18 Day
Date of IRB
Anticipated trial start date
2011 Year 07 Month 01 Day
Last follow-up date
2016 Year 06 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2011 Year 07 Month 11 Day
Last modified on
2015 Year 08 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007003

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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