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Trial Title:
Crisaborole Ointment for Skin Toxicity Induced by Cetuximab
NCT ID:
NCT06118047
Condition:
Metastatic Colorectal Cancer
Cetuximab
Skin Toxicity
Conditions: Official terms:
Colorectal Neoplasms
Cetuximab
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Crisaborole Ointment
Description:
Crisaborole ointment to be applied twice daily.
Arm group label:
Intervention group
Intervention type:
Drug
Intervention name:
Cetuximab
Description:
Cetuximab
Arm group label:
Intervention group
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.
Criteria for eligibility:
Criteria:
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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
WeiWei Xiao
Address:
City:
Guangzhou
Zip:
510060
Country:
China
Status:
Recruiting
Contact:
Last name:
WeiWei Xiao
Phone:
+8613710390520
Email:
xiaoww@sysucc.org.cn
Start date:
August 1, 2023
Completion date:
December 31, 2025
Lead sponsor:
Agency:
Sun Yat-sen University
Agency class:
Other
Source:
Sun Yat-sen University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06118047
