Metastatic Colorectal Cancer, Cetuximab, Skin Toxicity
Conditions
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.
Interventions
DRUGCetuximab
Cetuximab
Crisaborole ointment to be applied twice daily.
Sponsors
Sun Yat-sen University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Diagnosed mCRC and undergoing Cetuximab treatment; 2. ≥2 grade EGFR inhibitor-related acneiform eruption, evaluated by National Cancer Institute (NCI) Common Terminology Criteria Adverse Events (CTCAE）5.0; 3. Age 18 years and older； 4. ECOG performance status 0-2.； 5. Bone marrow ,brain, heart, kidney and other organ function well;； 6. Expected survival time more than 3 months;
Exclusion criteria
1. The presence of any active skin disease； 2. Undergoing any current hormone therapy for any other disease; 3. Prior allergic reaction or severe intolerance to crisaborole ointment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Cetuximab treatment discontinuation rate | 8 weeks from randomization. | Rate of Cetuximab treatment discontinuation due to skin toxicity |
| Cetuximab dose reduction rate | 8 weeks from randomization. | Rate of Cetuximab dose reduction due to skin toxicity |
| 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 |
| 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) |
| 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. |
Countries
China
Contacts
Primary ContactWeiwei Xiao
Backup ContactLiping Chen
Outcome results
None listed