A Phase III Trial of Standard Fractionation Radiation and Concurrent Single Agent Cisplatin, with and without Docetaxel, Cisplatin, and 5-Fluorouracil Induction Chemotherapy, in Patients with Advanced Oropharyngeal Squamous Cell Cancer

Pts must have previously untreated histologically proven dx of SCCHN of oropharynx based on bx or FNA of the primary lesion or neck mass. Pts with unknown primary site are not elig. Pts must have selected Stage III or selected Stage IV dz based on the AJCC 2002 Staging System. All pts must have neg CXR w/i 28 days prior to reg. Pts must undergo pre-tx evaluation by a H&N surgeon, to include EUA w/i 28 days prior to reg, w/ direct laryngoscopy and esophagoscopy. Surgeon must consider dz resectable for cure. Ineligible pts are those for whom surgical excision is unlikely to result in clear margins including pts as outlined in Section 5.3. Pts must be evaluated by Radiation & Medical Oncologist w/i 28 day prior to reg. Dz must have been determined to be appropriate for definitive RT w/ curative intent. Pts must have measurable and non-measurable dz at the primary oropharynx site documented by clinical exam, CT or MRI w/i 28 days prior to reg. The primary site and measurable dz must be assessed w/i 42 days prior to reg. Specimen submission is required for all pts who consent to specimen banking. Pts able to speak English and Spanish must complete the QOL forms w/i 14 days prior to reg (pts who cannot complete forms can register w/o contributing in the QOL study). Pts must not have myocardial infarction w/i the last 3 mo, no unstable or uncontrolled angina, and not active systemic infection. PS 0 - 1. No prior therapeutic srg and pts must not have had RT or chemo of any kind for any reason. Pts must have adequate hematologic, renal and hepatic function. Pts must not have pre-existing clinically significant motor or sensory neuropathy. Pregnant or nursing women may not elig.
Second registration – Pts must fulfill one of the following criteria: CR or PR at the primary site after 1 cycle of induction chemo; salvage surg following failure to achieve CR or PR at the primary site after 1 cycle of induction chemo, pt refusal surg following failure to achieve CR or PR at primary site after 1 cycle of induction chemo; failure to achieve CR or PR at the primary after 1 cycle of induction chemo and dz is deemed unresectable.