EGF ointment trial

JRCT ID: jRCTs041200113

Registered date:17/03/2021

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: colon cancer , rectal cancer
• Date of first enrollment: 12/07/2021
• Target sample size: 34
• Study type: Interventional
• Intervention(s): Administration of epidermal growth factor ointment

Outcome(s)

• Primary Outcome: Incidence of dose limiting toxicity ( DLT ) , Rate of improvement in skin rash
• Secondary Outcome: Safety of EGF ointment,Compliance with the treatment of EGF ointment, Total dosage of EGF ointment,patient reported outcome (PRO)

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include 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.

Exclude 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.

Related Information

• Primary Sponsor: Kiyohara Yoshio