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Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000005862
Receipt No. 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

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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
Email

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
Email

Sponsor
Institute National Cancer Center Hospital East
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006921

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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