Clinical trial NCT01979211: Post-operative Radiation With Cetuximab for Locally Advanced Cutaneous Squamous Cell Carcinoma of the Head and Neck
Official title: Phase II Trial of Post-operative or Definitive Concurrent Radiation and Cetuximab for Locally Advanced Cutaneous Squamous Cell Carcinoma of the Head and Neck
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Head and Neck Cancer
Keywords: head and neck cancer
Lead sponsor: University of Cincinnati
Sponsor class: OTHER
First posted: 2013-11-08
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Detailed description: This is a Phase II trial to characterize the feasibility of treating patients with locally advanced cutaneous squamous cell carcinomas of the head and neck with post-operative radiotherapy and cetuximab. Cetuximab has previously been given safely in conjunction with head and neck radiotherapy for mucosal squamous cell carcinoma in multiple phase III trials, and so Phase I data is not necessary here.

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

Primary outcomes:
measure: Percentage of Participants With Local Regional Control
timeFrame: 2 years
Secondary outcomes:
measure: Percentage of Participants With Disease-free Survival
timeFrame: 2 years
measure: Percentage of Participants With Overall Survival
timeFrame: 5 years
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: University of Cincinnati
state: Ohio
Study officials:
affiliation: University of Cincinnati
name: Vinita Takiar, MD
role: PRINCIPAL_INVESTIGATOR
References: