UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Phase II study of panitumumab rechallenge in the third-line therapy in patients with KRAS wild-type metastatic colorectal cancer
Title of the study (Brief title)	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	Akihito Tsuji
Organization	Kobe City Medical Center General Hospital
Division name	Clinical oncology
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	Masashi Fujii
Organization	Nonprofit Organization Japan Clinical Cancer Research Organization
Division name	Office
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 06 Month 21 Day
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

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