colon cancer , rectal cancer
Conditions
Interventions
Administration of epidermal growth factor ointment
Sponsors
Kiyohara Yoshio
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1)Patients with unresectable advanced or recurrent colorectal cancer histologically confirmed to be adenocarcinoma expressing RAS(KRAS / NRAS)wild type . (2)Patients received anti-EGFR agent(biweekly panitumumab / cetuximab) as first or later line treatment. (3)With holding of chemotherapy is needed due to Grade2 < = skin rash(other than the face), appeared in a certain area(10cm x 10cm or more). *Grading of skin rash is based on modified CTCAE v5.0-JCOG specified in this study. (4)ECOG performance status of 0 to 2. (5)Age (at the time of informed consent): 20 years and older. (6)Written informed consent was obtained after receiving a through explanation of the trial.
Exclusion criteria
Exclusion criteria: (1)Patients received continuous high-dose corticosteroids(equivalent to prednisolone 10mg or more) within 2 months before registration (except for systemic use , e.g., for reduction of chemocerapy-related nausea ) (2)Women who are pregnant or breastfeeding, women who have nointention of contraception during study drug or until 6months after the final administration of the study drug, or men who desire to bear children. (3)Patients hospitalized at the time of registration. (4)Other patients judged by the investigator or subinvestigator to be inappropriate as a subject of this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of dose limiting toxicity ( DLT ) , Rate of improvement in skin rash | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety of EGF ointment,Compliance with the treatment of EGF ointment, Total dosage of EGF ointment,patient reported outcome (PRO) | — |
Contacts
Public ContactKunihiro Fushiki
Shizuoka Cancer Center
Outcome results
None listed