UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005862 |
|---|---|
| Receipt number | R000006921 |
| Scientific Title | A phase 2 study, investigating prevention and treatment algorism of the skin toxicity related with Panitumumab treatment in patients with unresectable and/or metastatic CRC with KRAS wild type refractory to 5-FU containing chemotherapy |
| Date of disclosure of the study information | 2011/06/28 |
| Last modified on | 2011/06/28 02:10:03 |
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Basic information
Public title
A phase 2 study, investigating prevention and treatment algorism of the skin toxicity related with Panitumumab treatment in patients with unresectable and/or metastatic CRC with KRAS wild type refractory to 5-FU containing chemotherapy
Acronym
A phase 2 study, investigating prevention and treatment algorism of the skin toxicity related with Panitumumab treatment in patients with unresectable and/or metastatic CRC with KRAS wild type refractory to 5-FU containing chemotherapy
Scientific Title
A phase 2 study, investigating prevention and treatment algorism of the skin toxicity related with Panitumumab treatment in patients with unresectable and/or metastatic CRC with KRAS wild type refractory to 5-FU containing chemotherapy
Scientific Title:Acronym
A phase 2 study, investigating prevention and treatment algorism of the skin toxicity related with Panitumumab treatment in patients with unresectable and/or metastatic CRC with KRAS wild type refractory to 5-FU containing chemotherapy
Region
| Japan |
Condition
Condition
unresectable and/or metastatic colorectal cancer
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate efficacy of the protocol algorism of the skin toxicity related with Panitumumab treatment in patients with unresectable and/or metastatic CRC with KRAS wild type refractory to 5-FU containing chemotherapy. The protocol algorism contains the reactive topical steroid and pre-emptive minocycline hydrochloride 100mg twice per day administration with consistent skin moisturizer.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
incidence rates and timing of grade two or more skin toxicity during 6 weeks from Panitumumab contained chemotherapy started.
Key secondary outcomes
response rate, disease control rate, progression free survival, overall survival, any adverce event, sebum cutaneum measurment and stratum corneum hydration measurment from Panitumumab contained chemotherapy started.
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
pre-emptive administration of minocycline hydrochloride 100mg twice per day and consistent heparinoid containing skin moisturizer, which are started at panitumumab contained chemotherapy started. And reactive treatment of topical steroid; Hydrocortisone butyrate cream 0.1% apply to face, diflupredonate ointment 0.05% apply to the other part.
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
Patients who have unresectable and/or metastatic colorectal adenocarcinoma with KRAS wild type, history of progression of disease of 5-FU based chemotherapy as the first-line during the treatment or within 6 months after the last administration of the regimen, measurable lesion according to the RECIST version1.1, Eastern Cooperative Oncology Performance Status of 0-2, adequate major organ function and can comprehend and voluntarily sign the informed consent form.
Key exclusion criteria
Patients who have central nervous system metastasis, homozygote of UGT1A1 *28 or *6, double heterozygote of UGT1A1 *28 and *6, prior anti-EGFR therapy, unresolved toxicities from prior anthi-cancer therapy, clinically significant complication, pre- or co-existing interstitial pneumoniae, do not consent to use adequate contraceptive precausions with child-bearing potential, are breast-feeding or pregnant female.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takayuki Yoshino |
Organization
National Cancer Center Hospital East
Division name
Gastrointestinal oncology
Zip code
Address
6-5-1, Kashiwanoha, Kasiwa 277-8577, JAPAN
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
National Cancer Center Hospital East
Division name
Gastrointestinal oncology
Zip code
Address
6-5-1, Kashiwanoha, Kasiwa 277-8577, JAPAN
TEL
Homepage URL
Sponsor or person
Institute
National Cancer Center Hospital East
Institute
Department
Personal name
Funding Source
Organization
JASMIN(Japan Advanced Science and Medical Information Network; specified nonprofit corporaton)
Organization
Division
Category of Funding Organization
Non profit foundation
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
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 06 | Month | 28 | 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
| 2011 | Year | 02 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 06 | 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
| 2011 | Year | 06 | Month | 28 | Day |
Last modified on
| 2011 | Year | 06 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006921
