Unique ID issued by UMIN | UMIN000004883 |
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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 |
JAPANESE - Skin Toxicity Evaluation Protocol With Panitumumab as 3rd line treatment for Colorectal Cancer(J-STEPP),(HGCSG1001)
J-STEPP(HGCSG1001)
JAPANESE - Skin Toxicity Evaluation Protocol With Panitumumab as 3rd line treatment for Colorectal Cancer(J-STEPP),(HGCSG1001)
J-STEPP(HGCSG1001)
Japan |
unresectable advanced colorectal cancer
Gastroenterology | Hematology and clinical oncology | Dermatology |
Malignancy
YES
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.
Safety,Efficacy
Confirmatory
Explanatory
Phase II
Adverce event of skin toxicity
(>= grade2) during the 6 weeks from treatment started
Time to appearance of skin toxicity(each grade) ,Safety,Progression-free Survival, Overall Survival,Time-to-treatment-failure,Overall Response Rate
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
Active
YES
NO
Institution is considered as a block.
YES
Central registration
2
Treatment
Medicine |
panitumumab+skin moisturizers(8weeks)
panitumumab+skinmoisturizers+sunscreen+minocycline+topical steroid(8weeks)
20 | years-old | <= |
Not applicable |
Male and Female
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
(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.
102
1st name | |
Middle name | |
Last name | Yoshito Komatsu |
Hokkaido Gastrointestinal Cancer Study Group(HGCSG)
Hokkaido University Hospital Cancer Center
Cancer Chemotherapy
Kita 14, Nishi 5, Kita-ku, Sapporo
81-11-706-5657
ykomatsu@med.hokudai.ac.jp
1st name | |
Middle name | |
Last name | Yoshimitsu Kobayashi |
Hokkaido University Hospital
Cancer Center
Kita 14, Nishi 5, Kita-ku, Sapporo
81-11-706-5657
http://www.hgcsg.com/
bako_tearoom1020@yahoo.co.jp
Hokkaido Gastrointestinal Cancer Study Group(HGCSG)
Hokkaido Gastrointestinal Cancer Study Group(HGCSG)
Non profit foundation
Japan
none
none
NO
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
2011 | Year | 01 | Month | 15 | Day |
Partially published
Main results already published
2010 | Year | 06 | Month | 28 | Day |
2010 | Year | 07 | Month | 01 | Day |
2015 | Year | 06 | Month | 01 | Day |
2015 | Year | 06 | Month | 01 | Day |
2015 | Year | 12 | Month | 31 | Day |
2015 | Year | 12 | Month | 31 | Day |
2011 | Year | 01 | Month | 15 | Day |
2014 | Year | 07 | Month | 15 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004777
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