UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000004883
Receipt number 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 09:32:13

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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 or person

Institute

Hokkaido Gastrointestinal Cancer Study Group(HGCSG)

Institute

Department

Personal name



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

Value
https://center6.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