UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Randomized phase II trial of FOLFIRI with either panitumumab or bevacizumab as second-line treatment in patients with KRAS wild metastatic colorectal cancer refractory to oxaliplatin and bevacizumab with exploratory analysis to predict treatment efficacy and prognosis
Title of the study (Brief title)	FOLFIRI+Pmab vs FOLFIRI+BV as second-line for colorectal cancer
Region	Japan

Condition
Condition	Colorectal cancer
Classification by specialty	Gastroenterology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate efficacy and safety of FOLFIRI+BV and FOLFIRI+Pmab for metastatic colorectal cancer as second-line chemotherapy. To conduct subset analysis and translational research to predict treatment efficacy.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Phase II

Assessment
Primary outcomes	Overall survival
Key secondary outcomes	Progression freer survival, response rate, safety, translational research

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification	YES
Dynamic allocation	YES
Institution consideration	Institution is considered as adjustment factor in dynamic allocation.
Blocking	NO
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	FOLFIRI+panitumumab
Interventions/Control_2	FOLFIRI+bevacizumab
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)Patients with histopathologically proven metastatic or locally advanced colorectal adenocarcinoma 2) presence of radiographically or clinically confirmed disease progression during previous first-line chemotherapy using oxaliplatin, fluoropyrimidine, bevacizumab, or progression within 3 months after the last chemotherapy 3) KRAS with wild-type 4) Age>=20years 5) ECOG performance status 0-2. 6) The presence of evaluable disease, as defined by the RECIST criteria. 7) Treatment free interval with more than 2 weeks after last radiotherapy 8) Adequate bone marrow reserve (neutrophil count>=1200/mm3, platelet count>=75000/mm3, Hemoglobin level>=8g/dl), adequate hepatic function (AST and ALT<=100IU/L, or AST,ALT<=200IU/L with liver metastases, total bilirubin<=1.5mg/dl), Adequate renal function (serum creatinine<=1.5mg/dL, fulfill at least one of the following criteria; urine dipstick 1+ or less, urine protein creatinine (UPC) 1 or less, or 24-hour urine protein 1000mg or less) 9) Expected survival>= 90 days 10) Written informed consent obtained from the patient
Key exclusion criteria	1) previous history of chemotherapy including irinotecan, cetuximab, or panitumumab 2) symptomatic brain metastasis or brain metastasis with under medication 3) intestinal obstruction 4) uncontrollable ascites or pleural effusion 5) uncontrollable diarrhea 6) having other active malignancies 7) having active infections 8) pulmonary fibrosis or interstitial pneumonia 9) serious comorbidities, such as uncontrollable diabetes mellitus, severe heart disease (NYHA>III), renal failure, and liver failure 10) History of arterial thromboembolic events such as unstable angia, myocardial infarction, brain hemorrhage, and brain infarction within 6 months. 11) having wound healing problem (excluding central venous port) 12) History of major surgery within 28 days or 14 days after colostomy. 13) Meningitis carcinomatosis or uncontrollable seizures, serious mental problem or neurologic disorders 14) continuous steroid administration 15) serious drug allergy 16) HIV infection 17) Pregnant or lactating female 18) Other serious medical conditions.
Target sample size	200

Research contact person
Name of lead principal investigator	Kohei Shitara
Organization	National Cancer Center Hospital East
Division name	Department of Gastroenterology and Gastrointestinal Oncology
Address	6-5-1, Kashiwanoha, Kashiwa, Chiba, 277-8577 Japan
TEL	04-7133-1111
Email

Public contact
Name of contact person	Shinichiro Nakamura
Organization	West Japan Oncology Group
Division name	WJOG datacenter
Address	Namba Plaza Bldg.304-1-5-7,Motomachi Naniwa-ku,Osaka556-0016 JAPAN
TEL	06-6633-7400
Homepage URL
Email	datacenter@wjog.jp

Sponsor
Institute	West Japan Oncology Group
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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

Other administrative information
Date of disclosure of the study information	2011 Year 03 Month 08 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2011 Year 02 Month 26 Day
Anticipated trial start date	2011 Year 04 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Published
URL releasing results	https://www.ncbi.nlm.nih.gov/pubmed/27712015
Results
Other related information

Management information
Registered date	2011 Year 03 Month 08 Day
Last modified on	2017 Year 06 Month 01 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006197