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General Eligibility: |
Squamous cell carcinoma of the head and neck meeting the following criteria:
Gross total resection must be completed within 7 weeks of randomization, with pathology demonstrating one or more of the following risk factors:
Histologic extracapsular nodal extension; Histologic involvement of = 2 regional lymph nodes; Invasive cancer seen on microscopic evaluation of the resection margin, with no evidence of gross tumor residual.
NOTE: Early stage tonsil cancer patients who undergo transoral excision of all gross tumor are eligible if the patient has formal neck dissection confirming histologic extracapsular
nodal extension or histologic involvement of = 2 regional lymph nodes.
Site of tumor origin in the oral cavity, oropharynx, larynx, or hypopharynx (excluding lip, nasopharynx, or sinuses); Zubrod performance status of 0-1; Pretreatment evaluations required History and physical required 4 weeks prior to study entry Dental evaluation prior to radiation therapy.
Medical oncology evaluation Surgical evaluation and clearance prior to start of RT Laboratory studies within four weeks prior to study entry Serum pregnancy test, if applicable, within one week prior to study entry; urine dipstick test on the first day of treatment
Radiographic Studies:
Patients must be = 18 years of age;
Women of childbearing potential (WOCBP) and male participants must be willing to consent to using effective contraception while on treatment and for at least 3 months thereafter;
Pregnant or lactating women are ineligible
WOCBP must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin [hCG], or in accordance with local regulations.
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Purpose: |
To evaluate, using a random assignment phase II design, two treatment regimens that utilize the EGFR inhibitor C225 in combination with chemoradiation in high-risk postoperative head and neck patients. This trial is designed to determine if either regimen is promising enough to be pursued in a subsequent phase III study. This decision will be primarily based on whether there is improvement in disease-free survival relative to the RTOG database of similar patients treated with chemoradiation in the completed intergroup trial RTOG 9501.
To determine whether each of the treatment regimens can be delivered safely and successfully following surgical resection for advanced head and neck cancer;
To estimate the locoregional control and overall survival rates for patients treated with the each
regimen;
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