Chemoradiotherapy With Very Low Dose Elective Nodal IMRT for Locally Advanced Head & Neck Cancer: the CCRO11 Multi-Institutional Phase II Trial

Inclusion Criteria:

- Biopsy proven squamous cell carcinoma of oral cavity, oropharynx, hypopharynx, or
larynx

- No surgical resection of primary site or neck dissection (excisional biopsy of lymph
node is permitted)

- Human Papilloma Virus (HPV) testing of tumor performed; HPV p16 by
immunohistochemistry

- Stage III or IVa disease (T1-2N1-3M0, T3-4N0-3M0) excluding T1-2N1 oral cavity and
tonsil primaries and any N2C or bilateral N3 disease. Patients with T2N0 cancer of
the base of tongue and hypopharynx are eligible

- ECOG performance status 0-1

- Age >18 years

- No current pregnancy

- No other invasive malignancies within the last 2 years Patients with basal cell or
squamous cell skin cancers or carcinoma in situ of any site are eligible.

- No prior radiotherapy to the head and neck region

- No prior cisplatin chemotherapy

- No symptomatic coronary disease or myocardial infarction within the last 6 months

- Laboratory evaluation: ANC > 2,000/mm3, platelets >100,000/mm3, creatinine < 1.5
mg/dl, creatinine clearance > 50 ml/min, bilirubin < 1.5 mg/dl, AST or ALT < 2X upper
normal limit

- Study-specific consent signed prior to entry

Exclusion Criteria:

- Second primary malignancy that is clinically detectable

- Inability or unwillingness to comply with chemoRT

- Prior radiotherapy, chemotherapy, or investigational treatment for squamous cell
carcinoma of head and neck.

- Metastatic disease (M1)

- Pregnant or breast-feeding women.