Metastatic Colorectal CancerPhase 2COSTICNCT06118047
Crisaborole Ointment for Skin Toxicity Induced by Cetuximab
A Phase 2 study testing Crisaborole Ointment and Cetuximab in people with Metastatic Colorectal Cancer and Cetuximab, run by Sun Yat-sen University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Colorectal Cancer, Cetuximab, Skin Toxicity
- What is being tested?
- Crisaborole Ointment and Cetuximab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2023to 31 Dec 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
WeiWei Xiao
Guangzhou, Guangdong, 510060
WeiWei Xiao, +8613710390520, xiaoww@sysucc.org.cn
About this study
Official title: Efficacy and Safety of Crisaborole Ointment, a Phosphodiesterase 4 (PDE4) Inhibitor, for the Topical Treatment of Cetuximab-Related Skin Toxicity Among Metastatic Colorectal Cancer Patients：A Prospective, Single-arm, Phase II Clinical Trial
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.
Read the 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.
- Conditions
- Metastatic Colorectal Cancer, Cetuximab, Skin Toxicity
- Being tested
- Crisaborole Ointment, Cetuximab
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Crisaborole OintmentDrug
Crisaborole ointment to be applied twice daily.
CetuximabDrug
Cetuximab
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | crisaborole ointment Receives: Drug: Crisaborole Ointment; Drug: Cetuximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Remission 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.
Measured: From date of randomization until the date of remission，assessed up to 8 weeks.
Secondary outcomes (6)
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
Measured: 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
Measured: 8 weeks from randomization.
Cetuximab dose reduction rate
Rate of Cetuximab dose reduction due to skin toxicity
Measured: 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.
Measured: 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）
Measured: The 0,2,4,6,8,10,12 weeks from randomization.
Quality of life（EORTC QLQ-C30)
Questionnaire of the European Organisation for Research and Treatment of Cancer quality of life (EORTC QLQ-C30)
Measured: The 0,2,4,6,8,10,12 weeks from randomization.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2023
- Study start1 Aug 2023
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Metastatic Colorectal CancerStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 33 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, WeiWei Xiao, Sun Yat-sen University
- Investigators
- Weiwei Xiao, Principal investigator, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06118047
- Sponsor's protocol ID
- B2022-648
- Acronym
- COSTIC
- Status last verified
- Jul 2023
- First submitted
- 31 Oct 2023
- Last updated
- 7 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Kim YS, Ji JH, Oh SY, Lee S, Huh SJ, Lee JH, Song KH, Son CH, Roh MS, Lee GW, Lee J, Kim ST, Kim CK, Jang JS, Hwang IG, Ahn HK, Park LC, Oh SY, Kim SG, Lee SC, Lim DH, Lee SI, Kang JH. A Randomized Controlled Trial of Epidermal Growth Factor Ointment for Treating Epidermal Growth Factor Receptor Inhibitor-Induced Skin Toxicities. Oncologist. 2020 Jan;25(1):e186-e193. doi: 10.1634/theoncologist.2019-0221. Epub 2019 Sep 6.
PubMed 31492766Klufa J, Bauer T, Hanson B, Herbold C, Starkl P, Lichtenberger B, Srutkova D, Schulz D, Vujic I, Mohr T, Rappersberger K, Bodenmiller B, Kozakova H, Knapp S, Loy A, Sibilia M. Hair eruption initiates and commensal skin microbiota aggravate adverse events of anti-EGFR therapy. Sci Transl Med. 2019 Dec 11;11(522):eaax2693. doi: 10.1126/scitranslmed.aax2693.
PubMed 31826981Hofheinz RD, Lorenzen S, Trojan J, Ocvirk J, Ettrich TJ, Al-Batran SE, Schulz H, Homann N, Feustel HP, Schatz M, Kripp M, Schulte N, Tetyusheva M, Heeger S, Vlassak S, Merx K. EVITA-a double-blind, vehicle-controlled, randomized phase II trial of vitamin K1 cream as prophylaxis for cetuximab-induced skin toxicity. Ann Oncol. 2018 Apr 1;29(4):1010-1015. doi: 10.1093/annonc/mdy015.
PubMed 29360920Pinto C, Barone CA, Girolomoni G, Russi EG, Merlano MC, Ferrari D, Maiello E; American Society of Clinical Oncology; European Society of Medical Oncology. Management of skin toxicity associated with cetuximab treatment in combination with chemotherapy or radiotherapy. Oncologist. 2011;16(2):228-38. doi: 10.1634/theoncologist.2010-0298. Epub 2011 Jan 27.
PubMed 21273511Pinto C, Barone CA, Girolomoni G, Russi EG, Merlano MC, Ferrari D, Maiello E. Management of Skin Reactions During Cetuximab Treatment in Association With Chemotherapy or Radiotherapy: Update of the Italian Expert Recommendations. Am J Clin Oncol. 2016 Aug;39(4):407-15. doi: 10.1097/COC.0000000000000291.
PubMed 27077276
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Crisaborole Ointment, a Phosphodiesterase 4 (PDE4) Inhibitor, for the Topical Treatment of Cetuximab-Related Skin Toxicity Among Metastatic Colorectal Cancer Patients：A Prospective, Single-arm, Phase II Clinical Trial
- ClinicalTrials.gov ID
- NCT06118047
- Acronym / sponsor ID
- COSTIC / B2022-648
- Conditions
- Metastatic Colorectal Cancer, Cetuximab, Skin Toxicity
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 33 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 1 Aug 2023 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 7 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Drug: Crisaborole Ointment, Drug: Cetuximabcrisaborole ointment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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;；
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Crisaborole OintmentCrisaborole ointment to be applied twice daily. | Drug | Intervention group |
| CetuximabCetuximab | Drug | Intervention group |
Primary outcome
Remission rate of EGFR inhibitor-related acneiform eruption
Time frame: 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.
6 secondary outcomes
Remission time of EGFR inhibitor-related acneiform eruption
Time frame: From date of randomization until the date of remission，assessed up to 8 weeks.
Cetuximab treatment discontinuation rate
Time frame: 8 weeks from randomization.
Cetuximab dose reduction rate
Time frame: 8 weeks from randomization.
Level of paronychia, xeroderma and pruritus
Time frame: 8 weeks from randomization.
Quality of life (FACT-EGFRI-18)
Time frame: The 0,2,4,6,8,10,12 weeks from randomization.
Quality of life（EORTC QLQ-C30)
Time frame: The 0,2,4,6,8,10,12 weeks from randomization.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2023.
- Background: PubMed 31492766Kim YS, Ji JH, Oh SY, Lee S, Huh SJ, Lee JH, Song KH, Son CH, Roh MS, Lee GW, Lee J, Kim ST, Kim CK, Jang JS, Hwang IG, Ahn HK, Park LC, Oh SY, Kim SG, Lee SC, Lim DH, Lee SI, Kang JH. A Randomized Controlled Trial of Epidermal Growth Factor Ointment for Treating Epidermal Growth Factor Receptor Inhibitor-Induced Skin Toxicities. Oncologist. 2020 Jan;25(1):e186-e193. doi: 10.1634/theoncologist.2019-0221. Epub 2019 Sep 6.
- Background: PubMed 31826981Klufa J, Bauer T, Hanson B, Herbold C, Starkl P, Lichtenberger B, Srutkova D, Schulz D, Vujic I, Mohr T, Rappersberger K, Bodenmiller B, Kozakova H, Knapp S, Loy A, Sibilia M. Hair eruption initiates and commensal skin microbiota aggravate adverse events of anti-EGFR therapy. Sci Transl Med. 2019 Dec 11;11(522):eaax2693. doi: 10.1126/scitranslmed.aax2693.
- Background: PubMed 29360920Hofheinz RD, Lorenzen S, Trojan J, Ocvirk J, Ettrich TJ, Al-Batran SE, Schulz H, Homann N, Feustel HP, Schatz M, Kripp M, Schulte N, Tetyusheva M, Heeger S, Vlassak S, Merx K. EVITA-a double-blind, vehicle-controlled, randomized phase II trial of vitamin K1 cream as prophylaxis for cetuximab-induced skin toxicity. Ann Oncol. 2018 Apr 1;29(4):1010-1015. doi: 10.1093/annonc/mdy015.
- Background: PubMed 21273511Pinto C, Barone CA, Girolomoni G, Russi EG, Merlano MC, Ferrari D, Maiello E; American Society of Clinical Oncology; European Society of Medical Oncology. Management of skin toxicity associated with cetuximab treatment in combination with chemotherapy or radiotherapy. Oncologist. 2011;16(2):228-38. doi: 10.1634/theoncologist.2010-0298. Epub 2011 Jan 27.
- Background: PubMed 27077276Pinto C, Barone CA, Girolomoni G, Russi EG, Merlano MC, Ferrari D, Maiello E. Management of Skin Reactions During Cetuximab Treatment in Association With Chemotherapy or Radiotherapy: Update of the Italian Expert Recommendations. Am J Clin Oncol. 2016 Aug;39(4):407-15. doi: 10.1097/COC.0000000000000291.
- Individual participant dataSharing planned: Undecided
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CRC
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Weiwei Xiao principal investigator
Sun Yat-sen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Crisaborole Ointment and Cetuximab in people with Metastatic Colorectal Cancer and Cetuximab, run by Sun Yat-sen University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Weiwei Xiao (+8613710390520, xiaoww@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Remission rate of EGFR inhibitor-related acneiform eruption (time frame: From date of randomization until the date of remission，assessed up to 8 weeks.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06118047, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Nov 2023.