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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000007236
Receipt No. R000008527
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.
Date of disclosure of the study information 2012/02/07
Last modified on 2019/04/09

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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
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
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

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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