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JAPANESE - Skin Toxicity Evaluation Protocol With Panitumumab as 3rd line treatment for Colorectal Cancer(J-STEPP),(HGCSG1001)

JAPANESE - Skin Toxicity Evaluation Protocol With Panitumumab as 3rd line treatment for Colorectal Cancer(J-STEPP),(HGCSG1001) - J-STEPP(HGCSG1001)

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000004883
Enrollment
102
Registered
2011-01-15
Start date
2010-07-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

unresectable advanced colorectal cancer

Interventions

panitumumab+skin moisturizers(8weeks) panitumumab+skinmoisturizers+sunscreen+minocycline+topical steroid(8weeks)

Sponsors

Hokkaido Gastrointestinal Cancer Study Group(HGCSG)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria

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.

Design outcomes

Primary

MeasureTime frame
Adverce event of skin toxicity (>= grade2) during the 6 weeks from treatment started

Secondary

MeasureTime frame
Time to appearance of skin toxicity(each grade) ,Safety,Progression-free Survival, Overall Survival,Time-to-treatment-failure,Overall Response Rate

Countries

Japan

Contacts

Public ContactYoshimitsu Kobayashi

Hokkaido University Hospital Cancer Center

bako_tearoom1020@yahoo.co.jp81-11-706-5657

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026