UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007236 |
|---|---|
| Receipt number | 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 12:42:15 |
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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
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
takeshin@cc.okayama-u.ac.jp
Sponsor or person
Institute
Department of Gastroenterological Surgery, Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008527
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