UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Phase II study of panitumumab with FOLFOX or FOLFIRI as 1st line treatment in patients with metastatic colorectal cancer in Japan
Title of the study (Brief title)	Phase II study of panitumumab with FOLFOX or FOLFIRI as 1st line treatment for metastatic CRC in Japan (PaFF-J)
Region	Japan

Condition
Condition	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 with FOLFOX or FOLFIRI as 1st 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 (ORR)
Key secondary outcomes	- Safety - Progression free survival (PFS) - Overall survival (OS) - Time to progression (TTP) - Time to treatment failure (TTF) - Disease control rate - R0-resection rate - Histological investigation of the post-treatment liver tissues - Correlation between clinico-pathological factors and efficacy

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	The investigators choose the treatment A or Barbitrarily. A: FOLFOX + panitumumab B: FOLFIRI + panitumumab Repeat 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	80 years-old >=
Gender	Male and Female
Key inclusion criteria	1) Coloretal cancer (adenocarcinoma) 2) Unresectable 3) KRAS wild type 4) Age: 20-80 years old 5) ECOG performance status: 0-1 6) >=1 measurable lesion (at <=30 days prior to enrollment) 7) No prior chemotherapy and radiation thrpy (ex. adjuvant chmotherpy completed <=180 days prior to enrollmet) 8) Adequate organ functions as listed below (at <=14 days prior to enrollment) i) WBC: 3,000/mm3 to 12,000/mm3 ii) Neutrophl: >=1,500/mm3 iii) Plt: >=100,000/mm3 iv) Hb: >=9.0g/dL v) T-Bil: <=1.5mg/dL vi) AST(GOT): <=100*IU/L vii) ALT(GPT): <=100*IU/L *patients with liver metastas: <=200IU/L viii) Creatinine: <=1.2mg/dL 9) Expected survival >=3 months 10) Written informed concent
Key exclusion criteria	1) Prior severe drug allergy 2) Synchronous and/or metachronous multiple cancers 3) Severe bowel stenosis by the primary tumor (ex. after colostomy) 4) Prior adjuvant chemotherapy with oxaliplatin containing regimen 5) Surgical procedure within 28 days prior to enrollment (ex. venous reservoirs implant, colostomy) 6) Severe comorbidity: - severe pulmonary dysfunction - Uncontrolled DM - Uncontrolled HT - severe cardiovascular disease - Cirrhosis and liver failure - Renal failure 7) Sensory neuropathy 8) Severe diarrhea 9) Active infection 10) Symptomatic pleural effusion or ascites 11) Contraindications to 5-FU, l-LV, panitumumab, L-OHP or CPT-11 12) Concerning pregnancy 13) The investigator considers not suitable for the study
Target sample size	165

Research contact person
Name of lead principal investigator	Kenichi Sugihara, M.D., PhD
Organization	Tokyo Medical and Dental University, Graduate School
Division name	Dept. of Surgical Oncology
Address	1-5-45, Yushima, Bunkyo-ku, Tokyo, 113-8519, Japan
TEL	03-5803-5261
Email	k-sugi.srg2@tmd.ac.jp

Public contact
Name of contact person	Kenichi Sugihara, M.D., PhD
Organization	Tokyo Medical and Dental University, Graduate School
Division name	Dept. of Surgical Oncology
Address	1-5-45, Yushima, Bunkyo-ku, Tokyo, 113-8519, Japan
TEL	03-5803-5261
Homepage URL	http://www.ibri-kobe.org/
Email	k-sugi.srg2@tmd.ac.jp

Sponsor
Institute	Tokyo Medical and Dental University
Institute
Department

Funding Source
Organization	Foundation for Biomedical Research and Innovation
Organization
Division
Category of Funding Organization	Non profit foundation
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

Other administrative information
Date of disclosure of the study information	2011 Year 02 Month 26 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2011 Year 01 Month 28 Day
Anticipated trial start date	2011 Year 05 Month 01 Day
Last follow-up date	2015 Year 04 Month 01 Day
Date of closure to data entry	2015 Year 10 Month 28 Day
Date trial data considered complete	2015 Year 12 Month 23 Day
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
Other related information

Management information
Registered date	2011 Year 02 Month 01 Day
Last modified on	2017 Year 02 Month 05 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005934