Squamous Cell Cutaneous Carcinoma of the SkinC3NCT03325738
Cetuximab for Unresectable Cutaneous Squamous Cell Carcinoma - A National Retrospective Study
An observational study of Squamous Cell Cutaneous Carcinoma of the Skin, run by Centre Antoine Lacassagne at 1 site in France.
Trial summary
Localized cutaneous squamous cell carcinoma (CSCC) is usually treated by radical surgery with or without radiotherapy. The cure rate is high around 90% of cases (1). Unresectable CSCC represents less than 10% of all CSCC. The prognosis of these advanced forms is poor, without any proven treatment option. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Squamous Cell Cutaneous Carcinoma of the Skin
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- 30 Jun 2017to 11 Sep 2018
- Phase
- Observational
- 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
Study population: Patient with a confirmed squamous cell cutaneous carcinoma of the skin, locally Advanced or metastatic and who received a monotherapy treatment by cetuximab
Who may be able to join
- Histologically Confirmed squamous cell cutaneous carcinoma of the skin (SCCS)
- Locally advanced SCCS that is surgically unresectable, or metastatic SCCS, with documented progression, and who received a treatment of Cetuximab in monotherapy,
- Patients have to be anti EGFR-naïve,
- Age ≥ 18 years
- Eastern Cooperative Oncology Group performance status ≤ 2; life expectancy ≥ 3 months
- Presence of at least one measurable target lesion, according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria
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- Adequate hematologic, hepatic, and renal functions
- Available medical data
- Chemotherapy naïve patient in metastatic or locally advanced conditions (Cisplatinum used concomitantly with radiotherapy is allowed)
Who cannot join
- Prior radiotherapy within the last 4 weeks before the start of cetuximab (radiotherapy in concomitance with cetuximab is allowed if this is administrated in another lesion than the lesion treated by Cetuximab).
- Prior therapy with an agent that targets EGFR
- Instable systemic diseases or active uncontrolled infections.
Trial locations and contacts
1 site in 1 country.
About this study
Localized cutaneous squamous cell carcinoma (CSCC) is usually treated by radical surgery with or without radiotherapy. The cure rate is high around 90% of cases (1). Unresectable CSCC represents less than 10% of all CSCC. The prognosis of these advanced forms is poor, without any proven treatment option. The number of studies investigating systemic treatment of advanced or metastatic CSCC is limited, mostly based on phase II trials or case reports. Systemic treatment includes cytotoxic chemotherapy such as cisplatin and 5-Fluoro-uracil (5FU), immunotherapy (interferon alpha) or retinoic acid (13CRa) (1,2). Recently, epidermal growth factor receptor (EGFR) targeting agents have been explored (1,2). The anti-EGFR monoclonal antibody Cetuximab has shown some clinical efficacy in advanced CSCC alone or concomitant with radiotherapy or chemotherapy (3-5). A recent phase II study aimed at investigating the role of Cetuximab in 36 patients with unresectable CSCC (6). The authors reported a disease control rate at 6 weeks of 69% (95% CI, 52% to 84%). The best responses were eight partial responses and two complete responses. There were no Cetuximab-related deaths. There were three related serious adverse events: two grade 4 infusion reactions and one grade 3 interstitial pneumopathy. Grade 1 to 2 acne-like rash occurred in 78% of patients and was associated with prolonged Progression Free Survival (PFS) (6). The authors concluded that regarding the Cetuximab therapeutic index it could be interesting in this particular situation mainly for elderly patient. Unfortunately, the small number of patient included not allowed to draw definitive conclusion. It was interesting to note that the Disease rate control (DRC) with Cetuximab increased of 15% comparatively of DRC with chemotherapy. Additionally it seems that in case of efficacy the functional improvement of Cetuximab-sensitive patients occurred after very few infusions.
Taking these data together it seemed logical to design a larger retrospective clinical trial to confirm these results in "real life patients".
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Benefit of Cetuximab at 6 weeks
To Assess the clinical benefit (complete response [CR], partial response [PR], or stable disease [SD]) after 6 weeks of treatment with Cetuximab
Measured: 6 weeks
Secondary outcomes (7)
Objective response rate ORR
The ORR will be defined as the sum of partial responses plus complete responses after 6 weeks of treatment with Cetuximab.
Measured: December 2017
Overall survival OS
- The OS will be calculated between date of treatment beginning (Cetuximab) and the date of death for any reason. Patients who did not die at the time of analysis or are lost of follow-up will be censored at the date of the latest news.
Measured: December 2017
Progression free survival PFS
The PFS will be calculated between date of treatment beginning (Cetuximab) and date of progression, death or starting another anticancer treatment. Patients who did not progress, did not die at the time of analysis or are lost of follow-up will be censored at the date of the latest news.
Measured: December 2017
Cetuximab safety
The safety profile will be described using the common toxicity criteria from the NCI v4.03 and biological, including occurrence of acne-like rash.
Measured: December 2017
Overall response delay
The DOR will be measured from the time measurement criteria are first met for CR/PR until the first date that progressive disease is objectively documented (without other anticancer treatment).
Measured: December 2017
Disease stabilization delay
The DSD will be measured from the start of the treatment until the criteria for progression is objectively documented.
Measured: December 2017
Best overall response BOR
The BOR will be recorded from the start of the treatment until the end of treatment taking into account any requirement for confirmation.
Measured: December 2017
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2017
- Study start30 Jun 2017
- Primary completion30 Jun 2017
- Study completion11 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Squamous Cell Cutaneous Carcinoma of the SkinStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Antoine Lacassagne
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03325738
- Sponsor's protocol ID
- 2017/05
- Acronym
- C3
- Status last verified
- Jan 2019
- First submitted
- 26 Oct 2017
- Last updated
- 31 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cetuximab for Unresectable Cutaneous Squamous Cell Carcinoma - A National Retrospective Study
- ClinicalTrials.gov ID
- NCT03325738
- Acronym / sponsor ID
- C3 / 2017/05
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Centre Antoine LacassagneUniversity, hospital or other
- Study start
- 30 Jun 2017 (actual)
- Primary completion
- 30 Jun 2017 (actual)
- Study completion
- 11 Sep 2018 (actual)
- First posted
- 30 Oct 2017 (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.
Localized cutaneous squamous cell carcinoma (CSCC) is usually treated by radical surgery with or without radiotherapy. The cure rate is high around 90% of cases (1). Unresectable CSCC represents less than 10% of all CSCC. The prognosis of these advanced forms is poor, without any proven treatment option. The number of studies investigating systemic treatment of advanced or metastatic CSCC is limited, mostly based on phase II trials or case reports. Systemic treatment includes cytotoxic chemotherapy such as cisplatin and 5-Fluoro-uracil (5FU), immunotherapy (interferon alpha) or retinoic acid (13CRa) (1,2). Recently, epidermal growth factor receptor (EGFR) targeting agents have been explored (1,2). The anti-EGFR monoclonal antibody Cetuximab has shown some clinical efficacy in advanced CSCC alone or concomitant with radiotherapy or chemotherapy (3-5). A recent phase II study aimed at investigating the role of Cetuximab in 36 patients with unresectable CSCC (6). The authors reported a disease control rate at 6 weeks of 69% (95% CI, 52% to 84%). The best responses were eight partial responses and two complete responses. There were no Cetuximab-related deaths. There were three related serious adverse events: two grade 4 infusion reactions and one grade 3 interstitial pneumopathy. Grade 1 to 2 acne-like rash occurred in 78% of patients and was associated with prolonged Progression Free Survival (PFS) (6). The authors concluded that regarding the Cetuximab therapeutic index it could be interesting in this particular situation mainly for elderly patient. Unfortunately, the small number of patient included not allowed to draw definitive conclusion. It was interesting to note that the Disease rate control (DRC) with Cetuximab increased of 15% comparatively of DRC with chemotherapy. Additionally it seems that in case of efficacy the functional improvement of Cetuximab-sensitive patients occurred after very few infusions.
Taking these data together it seemed logical to design a larger retrospective clinical trial to confirm these results in "real life patients".
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient with a confirmed squamous cell cutaneous carcinoma of the skin, locally Advanced or metastatic and who received a monotherapy treatment by cetuximab
Key inclusion criteria (9 listed)
- Histologically Confirmed squamous cell cutaneous carcinoma of the skin (SCCS)
- Locally advanced SCCS that is surgically unresectable, or metastatic SCCS, with documented progression, and who received a treatment of Cetuximab in monotherapy,
- Patients have to be anti EGFR-naïve,
- Age ≥ 18 years
- Eastern Cooperative Oncology Group performance status ≤ 2; life expectancy ≥ 3 months
Key exclusion criteria (3 listed)
- Prior radiotherapy within the last 4 weeks before the start of cetuximab (radiotherapy in concomitance with cetuximab is allowed if this is administrated in another lesion than the lesion treated by Cetuximab).
- Prior therapy with an agent that targets EGFR
- Instable systemic diseases or active uncontrolled infections.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Clinical Benefit of Cetuximab at 6 weeks
Time frame: 6 weeks
To Assess the clinical benefit (complete response [CR], partial response [PR], or stable disease [SD]) after 6 weeks of treatment with Cetuximab
7 secondary outcomes
Objective response rate ORR
Time frame: December 2017
Overall survival OS
Time frame: December 2017
Progression free survival PFS
Time frame: December 2017
Cetuximab safety
Time frame: December 2017
Overall response delay
Time frame: December 2017
Disease stabilization delay
Time frame: December 2017
Best overall response BOR
Time frame: December 2017
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2019.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Squamous Cell Cutaneous Carcinoma of the Skin, run by Centre Antoine Lacassagne at 1 site in France.
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 9 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: finished, as of the sponsor's last update on 31 Jan 2019. 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 France. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical Benefit of Cetuximab at 6 weeks (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 31 Jan 2019.