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Name:
UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000004883
Receipt No. R000004777
Scientific Title JAPANESE - Skin Toxicity Evaluation Protocol With Panitumumab as 3rd line treatment for Colorectal Cancer(J-STEPP),(HGCSG1001)
Date of disclosure of the study information 2011/01/15
Last modified on 2014/07/15

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Basic information
Public title JAPANESE - Skin Toxicity Evaluation Protocol With Panitumumab as 3rd line treatment for Colorectal Cancer(J-STEPP),(HGCSG1001)
Acronym J-STEPP(HGCSG1001)
Scientific Title JAPANESE - Skin Toxicity Evaluation Protocol With Panitumumab as 3rd line treatment for Colorectal Cancer(J-STEPP),(HGCSG1001)
Scientific Title:Acronym J-STEPP(HGCSG1001)
Region
Japan

Condition
Condition unresectable advanced colorectal cancer
Classification by specialty
Gastroenterology Hematology and clinical oncology Dermatology
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 To evaluate the efficacy and safety of prophylactic and symptomatic treatments for skin toxicity observed in patients with colorectal cancer who are receiving 3rd-line irinotecan-based chemotherapy or monotheraphy concomitantly with panitumumab.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Phase II

Assessment
Primary outcomes Adverce event of skin toxicity
(>= grade2) during the 6 weeks from treatment started
Key secondary outcomes Time to appearance of skin toxicity(each grade) ,Safety,Progression-free Survival, Overall Survival,Time-to-treatment-failure,Overall Response Rate

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification YES
Dynamic allocation NO
Institution consideration Institution is considered as a block.
Blocking YES
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 panitumumab+skin moisturizers(8weeks)
Interventions/Control_2 panitumumab+skinmoisturizers+sunscreen+minocycline+topical steroid(8weeks)
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. Histologically confirmed adenocarcinoma of the colon and rectum
2. KRAS wild type
3. Patients failed to second line treatment with confirmed target lesion
4. ECOG performance status of 0,1,2
5. Life expectancy of longer than 3 months
6. Written informed consent
7.Good function of critical organs
WBC>=3,000/mm3 (neutrophil>=1,500)
Platelets>=75,000/mm3
Hemoglobin>=8.0g/dl
Total bilirubin<=1.5x each hospitals criteria
AST/ALT/ALP<=2.5x each hospitals criteria(liver/bone metastasis<=5xeach hospitals criteria)
Creatinine<=2.0x each hospitals criteria
Key exclusion criteria (a)Patient who have previous history of hypersensitivity in Panitumumab and other medicines
(b)The KRAS mutation type.
(c)pregnant woman or possibility pregnancy while suckling walking
(d)Patient with interstitial pneumonia
(e)the anti-EGFR antibody had been administered so far.
(f)Patient who is administering bevacizumab
(g)Patient who is judged improper by Doctor.
Target sample size 102

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoshito Komatsu
Organization Hokkaido Gastrointestinal Cancer Study Group(HGCSG)
Hokkaido University Hospital Cancer Center
Division name Cancer Chemotherapy
Zip code
Address Kita 14, Nishi 5, Kita-ku, Sapporo
TEL 81-11-706-5657
Email ykomatsu@med.hokudai.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yoshimitsu Kobayashi
Organization Hokkaido University Hospital
Division name Cancer Center
Zip code
Address Kita 14, Nishi 5, Kita-ku, Sapporo
TEL 81-11-706-5657
Homepage URL http://www.hgcsg.com/
Email bako_tearoom1020@yahoo.co.jp

Sponsor
Institute Hokkaido Gastrointestinal Cancer Study Group(HGCSG)
Institute
Department

Funding Source
Organization Hokkaido Gastrointestinal Cancer Study Group(HGCSG)
Organization
Division
Category of Funding Organization Non profit foundation
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor none
Name of secondary funder(s) none

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 愛育病院
NTT東日本札幌病院
市立札幌病院
北海道大学病院第三内科
北海道大学病院腫瘍内科
北海道消化器科病院
北楡病院
市立函館病院
函館中央病院
苫小牧日翔病院
苫小牧市立病院
釧路労災病院
網走厚生病院
北見日赤病院
市立稚内病院
岩見沢市立総合病院
その他

Other administrative information
Date of disclosure of the study information
2011 Year 01 Month 15 Day

Related information
URL releasing protocol
Publication of results Partially published

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 Main results already published
Date of protocol fixation
2010 Year 06 Month 28 Day
Date of IRB
Anticipated trial start date
2010 Year 07 Month 01 Day
Last follow-up date
2015 Year 06 Month 01 Day
Date of closure to data entry
2015 Year 06 Month 01 Day
Date trial data considered complete
2015 Year 12 Month 31 Day
Date analysis concluded
2015 Year 12 Month 31 Day

Other
Other related information

Management information
Registered date
2011 Year 01 Month 15 Day
Last modified on
2014 Year 07 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004777

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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