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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000011440
Receipt No. R000013393
Scientific Title Phase II study of panitumumab rechallenge in the third-line therapy in patients with KRAS wild-type metastatic colorectal cancer
Date of disclosure of the study information 2013/08/12
Last modified on 2019/03/08

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Basic information
Public title Phase II study of panitumumab rechallenge in the third-line therapy in patients with KRAS wild-type metastatic colorectal cancer
Acronym JACCRO CC-09 study
Scientific Title Phase II study of panitumumab rechallenge in the third-line therapy in patients with KRAS wild-type metastatic colorectal cancer
Scientific Title:Acronym JACCRO CC-09 study
Region
Japan

Condition
Condition metastatic colorectal cancer
Classification by specialty
Gastroenterology Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the efficacy and safety of panitumumab rechallenge in the third-line therapy in patients with KRAS wild-type metastatic colorectal cancer with clinical response in the first-line panitumumab containing therapy
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes 3-Month Progression Free Survival Rate
Key secondary outcomes response rate
disease control rate
overall survival
progression free survival
time to treatment failure
safety

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 panitumumab + irinotecan
panitumumab 6mg/Kg/bi-weekly
irinotecan 150 mg/m2/bi-weekly
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) Ptients with histologically proven colorectal cancer
(2) KRAS wild-type
(3) Patients showing clinical response (CR, PR or SD continuing 6 months or more) in first line panitumumab conbination therapy
(4) First-line therapy with oxaliplatin and secomd-line therapy with irinotecan, or first-line therapy with irinotecan and second-line therapy with oxaliplatin
(5) Patients with second-line therapy exept anti-EGFR antibody and regorafenib
(6) Presence of evaluable lesion defined by RECIST criteria
(7) ECOG performance status 0-2
(8) Age 20 years old or older
(9) Life expectancy of 3 months or longer
(10) Patients have enough organ function for study treatment assesed within 14 days before enrollment
(11) Written informed consent
Key exclusion criteria (1) Synchronous multiple maligmancy or metachronous multiple malignancy within 5 years disease free interval
(2) Symptomatic brain metastases
(3) Severe infectious disease
(4) Comorbidity or history of interstitial lung disease or pulmonary fibrosis
(5) Comorbidity or history of severe heart disease
(6) Sensory alteration or paresthesia interfering with function
(7) Large quantity of pleural, abdominal or cardiac effusion
(8) Severe comobidity (renal failure, liver failure, hypertensio, etc)
(9) Prio radiotherapy for primary and metastatic tumor
(10) Men/women who are unwilling to avoid pregnancy. Women who are pregnant or breastfeeding. Women with a positive pregnancy test
(11) Any other cases who are regarded as inadequate for study enrillment by investigators
Target sample size 35

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Akihito Tsuji
Organization Kobe City Medical Center General Hospital
Division name Clinical oncology
Zip code
Address 2-1-1 Minatojima-minamimachi, Chuo-Ku, Kobe 650-0047, Japan
TEL 078-302-4321
Email tsuji@kcho.jp

Public contact
Name of contact person
1st name
Middle name
Last name Masashi Fujii
Organization Nonprofit Organization Japan Clinical Cancer Research Organization
Division name Office
Zip code
Address 1-14-5 Ginza, Chuo-ku, Tokyo 104-0061, Japan
TEL 03-5579-9882
Homepage URL
Email cc09.dc@jaccro.or.jp

Sponsor
Institute Nonprofit Organization Japan Clinical Cancer Research Organization
Institute
Department

Funding Source
Organization Takeda Pharmaceutical Company Limited
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization Japan

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 神戸市立医療センター中央市民病院(兵庫県)ほか、JACCRO参加施設

Other administrative information
Date of disclosure of the study information
2013 Year 08 Month 12 Day

Related information
URL releasing protocol http://www.jaccro.com/
Publication of results Partially published

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 Completed
Date of protocol fixation
2013 Year 06 Month 21 Day
Date of IRB
Anticipated trial start date
2013 Year 08 Month 12 Day
Last follow-up date
2018 Year 09 Month 30 Day
Date of closure to data entry
2018 Year 11 Month 05 Day
Date trial data considered complete
2018 Year 11 Month 05 Day
Date analysis concluded
2019 Year 02 Month 01 Day

Other
Other related information

Management information
Registered date
2013 Year 08 Month 10 Day
Last modified on
2019 Year 03 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013393

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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