UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004574 |
|---|---|
| Receipt number | R000005414 |
| Scientific Title | Multicenter phase II trial of panitumumab plus irinotecan and S-1 (PIRIS regimen) in patients treated by oxaliplatin-based chemotherapy with K-RAS wild-type advanced colorectal cancer. |
| Date of disclosure of the study information | 2010/12/01 |
| Last modified on | 2011/02/09 15:29:10 |
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Basic information
Public title
Multicenter phase II trial of panitumumab plus irinotecan and S-1 (PIRIS regimen) in patients treated by oxaliplatin-based chemotherapy with K-RAS wild-type advanced colorectal cancer.
Acronym
Phase II trial of panitumumab plus irinotecan and S-1 (PIRIS regimen) in patients treated by L-OHP-based chemotherapy with advanced colorectal cancer.
Scientific Title
Multicenter phase II trial of panitumumab plus irinotecan and S-1 (PIRIS regimen) in patients treated by oxaliplatin-based chemotherapy with K-RAS wild-type advanced colorectal cancer.
Scientific Title:Acronym
Phase II trial of panitumumab plus irinotecan and S-1 (PIRIS regimen) in patients treated by L-OHP-based chemotherapy with advanced colorectal cancer.
Region
| Japan |
Condition
Condition
Colorectal Cancer
Classification by specialty
| Gastroenterology | Hematology and clinical oncology | Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate response rate of panitumumab, irinotecan and S-1 in previously treated patients with K-RAS wild-type advanced colorectal cancer.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
Response ratte : RR
Key secondary outcomes
1)Progression free survival :PFS
2)Time to treatment failure :TTF
3)Overall survival :OS
4)Skin toxitiy
5)Adverse Event :AE
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
Take care of skin before the PIRIS regimen (moistureizer,sunscreen,steroid, antibiotic).
Day1/Day15
panitumumab 6mg/kg
irinotecan 125mg/m2
Day1~14
S-1 80-120mg/m2
q4w(until progressive disease)
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1)Histopathologically confirmed colorectal cancer.
2)Evaluable tumor lesions.
3)Colorectal cancer that is not amenable to curative resection and have previously received chemotherapy containing oxaliplatin-based chemotherapy or relapsed within six months (or during its treatment) after adjuvant of FOLFOX.
4)K-RAS wild-type.
5)Oral administration of S-1 is possible.
6)ECOG Performance status(PS) of 0-2.
7)Age of 20 years or older.
8)A life expectancy of more than 12 weeks.
9)No severe organ failure: and suitable results of all laboratory test performed within 7 days before enrollment.
White blood cell count >= 3,000/mm3 and <= 12,000/mm3 or neutrophil count >= 1,500/mm3
platelet count >= 75,000/mm3
AST(GOT) and ALT(GPT) <= 3 times the institutional upper limit of normal or <= 5 times if the patient has liver metastasis
Total bilirubin <= 2.0mg/dL
serum creatinine <= 1.2 times the institutional upper limit of normal
10)Written informed consent will be obtained from each patient before enrollment.
11)Periods from prior treatment have elapsed more than two weeks.
Key exclusion criteria
1)A history of CPT-11 or cetuximab (C225) use.
2)A history of serious drug hypersensitivity or serious drug allergy.
3)Clinically important infection or suspected infection in febrile patients.
4)Diarrhea(watery) or diarrhea that interferes with daily activities for patients with a stoma.
5)Active double cancer.
6)Paralytic or occlusive ileus.
7)Uncontrolled body cavity fluid.
8)Symptomatic brain metastasis.
9)Clinically significant heart disease.
10)Severe pulmonary disease.
11)Gastrointestinal ulceration or bleeding.
12)Central nervous system disorders.
13)Uncontrolled diabetes.
14)Women who are pregnant, lactating, or wish to become pregnant or men who expect babies.
15)Judged to be unsuitable for this trial due to clinically significant mental / psychological disease etc.
16)Under treatment with atazanavir, flucytosine, phenytoin, warfarin potassium
17)Judged to be ineligible by principal investigator for any other reason.
Target sample size
48
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Ken Shimada |
Organization
Showa University Nothern Yokohama Hospital
Division name
department of internal medicine
Zip code
Address
Chigasaki-chuo 35-1 Tsuzuki-ku, Yokohama 224-503, Japan.
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Sotarou akatsuka |
Organization
Yokohama Rosai Hospital
Division name
Division of Medical Oncology
Zip code
Address
3211 Kozukue-Chō, Kōhoku-Ku, Yokohama City, Kanagawa Prefecture, Japan
TEL
045-474-8111
Homepage URL
Sponsor or person
Institute
Showa University Nothern Yokohama Hospital
Institute
Department
Personal name
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)
IRB Contact (For public release)
Organization
Address
Tel
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
神奈川県立がんセンター（消化器内科、神奈川県）、北里大学東病院(消化器内科、神奈川県)、済生会横浜市東部病院(消化器外科、消化器内科、神奈川県)、昭和大学藤が丘病院(外科、神奈川県）、昭和大学横浜市北部病院（内科、神奈川県）
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 12 | Month | 01 | 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
Results
Results date posted
Results Delayed
Results Delay Reason
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
Open public recruiting
Date of protocol fixation
| 2010 | Year | 10 | Month | 18 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 12 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2010 | Year | 11 | Month | 17 | Day |
Last modified on
| 2011 | Year | 02 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005414
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| Registered date | File name |
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