Adult Clinical Trials:HEAD AND NECK

RTOG 0920

A Phase III Study of Postoperative Radiation Therapy (IMRT) +/- Cetuximab for Locally-Advanced Resected Head and Neck Cancer

Pathologically (histologically) proven diagnosis of squamous cell carcinoma (including variants such as verrucous carcinoma, spindle cell carcinoma, carcinoma NOS, etc.) of the head/neck (oral cavity, oropharynx or larynx)

• Clinical stage T1, N1-2 or T2-3, N0-2, M0 including no distant metastases; Gross total resection of the primary tumor with curative intent must be completed within 7 weeks of registration with surgical pathology demonstrating one or more of the following "intermediate" risk factors:
• Perineural invasion and or Lymphovascular invasion;
• Single lymph node > 3cm or > 2 lymph nodes (all < 6cm) (no extracapsular extension);
• Close margin (s) of resection, defined as cancer extending to within 5mm of a surgical margin;
• T3 or microscopic T4a primary tumor (Note: Gross T4a or T4b is ineligible); 
• T2 oral cavity cancer with > 5mm depth of invasion.
• Adequate bone marrow, hepatic, and renal function as specified in the protocol;
• Patients must provide study specific informed consent prior to study entry, including consent for mandatory tissue submission for EGFR and for oropharyngeal patients, HPV analyses.

Treatment:
Arm 1: Radiation Therapy Alone, 2 Gy/day, in 30 fractions for a total of 60 Gy*
Arm 2: Radiation Therapy + Cetuximab

• At least 5 days prior to RT: Cetuximab: Initial dose, 400 mg/m2
• RT: 2 Gy/day in 30 fractions for a total of 60 Gy* plus cetuximab, 250 mg/m2/week x 6 weeks
• plus cetuximab: 250 mg/m2/week x 4 weeks post-RT

*IMRT is mandatory. Dose is 60 Gy prescribed to at least 95% of the PTV. If IGRT is used, it should be daily to assure that error/variance is < 3.5 mm. Note: 66 Gy is permitted and optional.

Note: Prior to stratification and randomization, all patients must consent to submission of tissue for required EGFR analysis; analysis results are expected in approximately 7-8 business days. At that time, patients with non-oropharyngeal carcinoma can be randomized. In addition, patients with oropharyngeal carcinoma must consent to use of the submitted tissue for required HPV analysis; analysis results are expected in approximately 7-10 business days. At that time, patients with oropharyngeal carcinoma can be randomized. All institutions will receive a 0.5 case credit for submission of tissue for analysis. See Section 5.5 for details of registration/randomization.