This is a prospective, single-arm, phase II clinical trial that will enroll metastatic colorectal cancer patients with Cetuximab-Related Skin Toxicity, who will receive crisaborole ointment twice daily.
The efficacy of cetuximab has been demonstrated in treating metastatic colorectal cancer (mCRC). Skin toxicities, especially acneiform eruption, are the major side effects associated with cetuximab, which affect patients' quality of life and can lead to treatment discontinuation and cetuximab dose reduction. This prospective, single-arm, phase II clinical trial aims to explore the efficacy and safety of crisaborole ointment in Cetuximab-Related Skin Toxicity. A total of 33 mCRC patients with acneiform eruption will be enrolled. All of the participants will receive crisaborole ointment twice daily. The total follow-up time is 12 weeks.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
33
Crisaborole ointment to be applied twice daily.
Cetuximab
WeiWei Xiao
Guangzhou, Guangdong, China
RECRUITINGRemission rate of EGFR inhibitor-related acneiform eruption
Grading of acneiform eruption would be assessed according to National Cancer Institute (NCI) Common Terminology Criteria Adverse Events (CTCAE) 5.0. Remission was defined as a reduction in acneiform eruption from grade 2 to grade 1 or grade 3 to grade 2 sustained for at least 2 weeks.
Time frame: From date of randomization until the date of remission，assessed up to 8 weeks.
Remission time of EGFR inhibitor-related acneiform eruption
Grading of acneiform eruption would be assessed according to NCI-CTCAE 5.0. Remission was defined as a reduction in acneiform eruption from grade 2 to grade 1 or grade 3 to grade 2 sustained for at least 2 weeks
Time frame: From date of randomization until the date of remission，assessed up to 8 weeks.
Cetuximab treatment discontinuation rate
Rate of Cetuximab treatment discontinuation due to skin toxicity
Time frame: 8 weeks from randomization.
Cetuximab dose reduction rate
Rate of Cetuximab dose reduction due to skin toxicity
Time frame: 8 weeks from randomization.
Level of paronychia, xeroderma and pruritus
Grading of paronychia, xeroderma and pruritus would be assessed according to NCI-CTCAE 5.0.
Time frame: 8 weeks from randomization.
Quality of life (FACT-EGFRI-18)
Functional Assessment of Cancer Therapy （FACT）questionnaire to assess dermatologic symptoms associated with epidermal growth factor receptor inhibitors （FACT-EGFRI-18）
Time frame: The 0,2,4,6,8,10,12 weeks from randomization.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Quality of life（EORTC QLQ-C30)
Questionnaire of the European Organisation for Research and Treatment of Cancer quality of life (EORTC QLQ-C30)
Time frame: The 0,2,4,6,8,10,12 weeks from randomization.