Crisaborole Ointment for Skin Toxicity Induced by Cetuximab
- Conditions
- Metastatic Colorectal CancerCetuximabSkin Toxicity
- Interventions
- Registration Number
- NCT06118047
- Lead Sponsor
- Sun Yat-sen University
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 33
- Diagnosed mCRC and undergoing Cetuximab treatment;
- ≥2 grade EGFR inhibitor-related acneiform eruption, evaluated by National Cancer Institute (NCI) Common Terminology Criteria Adverse Events (CTCAE）5.0;
- Age 18 years and older；
- ECOG performance status 0-2.；
- Bone marrow ,brain, heart, kidney and other organ function well;；
- Expected survival time more than 3 months;
- The presence of any active skin disease；
- Undergoing any current hormone therapy for any other disease;
- Prior allergic reaction or severe intolerance to crisaborole ointment
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Intervention group Crisaborole Ointment crisaborole ointment Intervention group Cetuximab crisaborole ointment
- Primary Outcome Measures
Name Time Method Remission rate of EGFR inhibitor-related acneiform eruption From date of randomization until the date of remission，assessed up to 8 weeks. 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.
- Secondary Outcome Measures
Name Time Method Remission time of EGFR inhibitor-related acneiform eruption From date of randomization until the date of remission，assessed up to 8 weeks. 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
Cetuximab dose reduction rate 8 weeks from randomization. Rate of Cetuximab dose reduction due to skin toxicity
Cetuximab treatment discontinuation rate 8 weeks from randomization. Rate of Cetuximab treatment discontinuation due to skin toxicity
Level of paronychia, xeroderma and pruritus 8 weeks from randomization. Grading of paronychia, xeroderma and pruritus would be assessed according to NCI-CTCAE 5.0.
Quality of life (FACT-EGFRI-18) The 0,2,4,6,8,10,12 weeks from randomization. Functional Assessment of Cancer Therapy （FACT）questionnaire to assess dermatologic symptoms associated with epidermal growth factor receptor inhibitors （FACT-EGFRI-18）
Quality of life（EORTC QLQ-C30) The 0,2,4,6,8,10,12 weeks from randomization. Questionnaire of the European Organisation for Research and Treatment of Cancer quality of life (EORTC QLQ-C30)
Trial Locations
- Locations (1)
WeiWei Xiao
🇨🇳Guangzhou, Guangdong, China