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Cetuximab for Unresectable Cutaneous Squamous Cell Carcinoma - A National Retrospective Study

NCT03325738 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 60

Last updated 2019-01-31

No results posted yet for this study

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. 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".

Conditions

  • Squamous Cell Cutaneous Carcinoma of the Skin

Sponsors & Collaborators

  • Centre Antoine Lacassagne

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-06-30
Primary Completion
2017-06-30
Completion
2018-09-11

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03325738 on ClinicalTrials.gov