UMIN-CTR Clinical Trial

Basic information
Public title	A multicenter phase II trial of TS-1+oxaliplatin+panitumumab as first-line treatment in patients with kras-wild type unresectable advanced colorectal liver metastasis.
Acronym	A multicenter phase II trial of TS-1+oxaliplatin+panitumumab as first-line treatment in patients with kras-wild type unresectable advanced colorectal liver metastasis.
Scientific Title	A multicenter phase II trial of TS-1+oxaliplatin+panitumumab as first-line treatment in patients with kras-wild type unresectable advanced colorectal liver metastasis.
Scientific Title:Acronym	A multicenter phase II trial of TS-1+oxaliplatin+panitumumab as first-line treatment in patients with kras-wild type unresectable advanced colorectal liver metastasis.
Region	Japan

Condition
Condition	colorectal cancer
Classification by specialty	Gastroenterology Gastrointestinal surgery
Classification by malignancy	Malignancy
Genomic information	YES

Objectives
Narrative objectives1	To verify efficacy and safety of TS-1+oxaliplatin+panitumumab as first-line treatment in patients with kras-wild type unresectable advanced colorectal liver metastasis.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Phase II

Assessment
Primary outcomes	RR: response rate
Key secondary outcomes	OS: overall survival PFS: progression free survival treatment completion rate 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	Dosing period: until progression disease Dose: TS-1 80mg/m2 (day1 to day15) Oxaliplatin 130mg/m2 (day1) panitumumab 6mg/kg (day1) every 3 weeks
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) Histopathological confirmation of Adenocarcinoma located in colon and rectosigmoid. 2) KRAS wild type (in codon 12, 13) confirmed, either in the primary tumor or in metastatic tumor lesion 3) Patient with unresectable synchronous or metachronous liver metastasis 4) Age of 20~80 5) ECOG performance status of 0 to 1 6) Presence of at least one measurable lesion according to RECIST 7) Patient without prior chemotherapy or radiation therapy 8) Sufficient function of important organs 1. WBC:>= 3,000 /mm3 2. Neu : >= 1,500 /mm3 3. Platelet : >= 100,000 /mm3 4. Hemoglobin : >= 9.0 g/dL 5. Sr.bil : <= 2.0 mg/dL 6. AST, ALT : <= 100IU/L 7. Serum creatinine : <= 1.2mg/dL 8. Ccr : >= 50 ml/min 9) Sufficient oral intake 10) Expected more than 3 months survival 11) With written informed consent
Key exclusion criteria	1) History of severe allergy 2) Administration contraindication of oxaliplatin, panitumumab, TS-1, or 5FU 3) Severe infectious disease 4) Severe complications (interstitial lung disease or pulmonary fibrosis, , kidney failure, hepatic failure, uncontrolable diabetes, uncontrolable hypertension) 5) History of interstitial lung disease or pulmonary fibrosis 6) Severe heart failure or history of severe heart failure 7) Peripheral sensory 8) Wattery diarrhea 9) Massive pleural effusion or ascites 10) Gastrointestinal perforation or bleeding 11) Patient medicated with anticoagulant drugs (except for low-dose aspirin [less than 325mg/day]) 12) Synchronous or metachronous (within 5 years) malignancy other than carcinoma in situ 13) Pregnant or lactating women or women of childbearing potential, and no birth-control 14) Mechanical bowel obstruction 15) Active hepatitis type B 16) Any other cases who are regarded as inadequate for study enrollment by the investigator.
Target sample size	40

Research contact person
Last name of lead principal investigator	1st name Toshiyoshi Middle name Last name Fujiwara
Organization	Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Division name	Department of Gastroenterological Surgery
Zip code	700-8558
Address	2-5-1 Shikata-cho, Kita-ku, Okayama, Japan
TEL	086-235-7257
Email	takeshin@cc.okayama-u.ac.jp

Public contact
1st name of contact person	1st name Takeshi Middle name Last name Nagasaka
Organization	Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Division name	Department of Gastroenterological Surgery
Zip code	700*8558
Address	2-5-1 Shikata-cho, Kita-ku, Okayama, Japan
TEL	086-235-7257
Homepage URL
Email	takeshin@cc.okayama-u.ac.jp

Sponsor
Institute	Department of Gastroenterological Surgery, Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Institute
Department

Funding Source
Organization	Department of Gastroenterological Surgery, Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Address	2-5-1, shikata-cho, okayama
Tel	086-223-7151
Email	MAE6605@adm.okayama-u.ac.jp

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	2012 Year 02 Month 07 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	2
Results
Results date posted
Results Delayed	Delay expected
Results Delay Reason	Under anayze
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	Terminated
Date of protocol fixation	2012 Year 01 Month 25 Day
Date of IRB	2012 Year 01 Month 31 Day
Anticipated trial start date	2012 Year 02 Month 01 Day
Last follow-up date	2017 Year 01 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2012 Year 02 Month 07 Day
Last modified on	2019 Year 04 Month 09 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008527