Phase 2 N=24 Treatment

Post-operative Radiation With Cetuximab for Locally Advanced Cutaneous Squamous Cell Carcinoma of the Head and Neck

Head and Neck Cancer

Bottom Line

View on ClinicalTrials.gov: NCT01979211 ↗

Enrolled (actual)

Serious AEs

12.5%

Results posted

May 2022

Primary outcome: Primary: Percentage of Participants With Local Regional Control — 91.1 percentage of subjects

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Cetuximab (Drug); Radiation Therapy (Radiation)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: University of Cincinnati
Primary completion: Jan 2022

Outcome Measures

Outcome	Result	p-value
PRIMARY Percentage of Participants With Local Regional Control	91.1	—
SECONDARY Percentage of Participants With Disease-free Survival	70.8	—
SECONDARY Percentage of Participants With Overall Survival	56.1	—

Summary

The standard treatment of surgery followed by radiation therapy can stop tumors from growing in the head and neck region in most patients. However, the cancer can recur or can spread to other parts of the body. Cetuximab is a drug that may delay or prevent tumor growth by blocking certain cellular chemical pathways that lead to tumor development. It was approved by the United States Food and Drug Administration (FDA) in 2006 for the treatment of head and neck cancer. The purpose of this study is to determine how easily cetuximab can be added to treatment with radiation therapy in patients with cutaneous cancer of the head and neck. This study will also look at how well cetuximab added to radiation therapy works over time and how well this treatment is tolerated.

Eligibility Criteria

Inclusion Criteria

Pathologically (histologically) proven diagnosis of cutaneous squamous cell carcinoma of the head and neck
Clinical stage >/= T3 or >/= N1, M0 including no distant metastases
Gross total resection of the primary tumor with curative intent must be completed within 7 weeks of registration
Performance status of 0-1 within 2 weeks prior to registration
Age >/= 18
Adequate labs within 2 weeks prior to registration

Exclusion Criteria

Prior invasive malignancy unless disease free for a minimum of 3 years; noninvasive cancers (For example, carcinoma in situ of the breast, oral cavity, or cervix are all permissible) are permitted even if diagnosed and treated < 3 years ago. Patients with a history of T1-2, N0, M0 resected differentiated thyroid carcinoma are considered eligible.
Prior systemic chemotherapy or anti-epidermal growth factor therapy for the study cancer or for a different prior cancer
Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01979211). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.