Post-operative Concurrent Chemo-radiotherapy Versus Post-operative Radiotherapy for Cancer of the Head and Neck

Inclusion Criteria:

* Histologically proven SCC
* Patients have undergone either:

  * Resection of the primary lesion
  * Any type of parotidectomy (superficial, total, partial, etc.)
  * Any type of neck dissection(s)
* High risk feature(s); Advanced primary disease or high risk nodal disease

High Risk Nodal Disease

* Intra-parotid nodal disease (any number or size, with/without extracapsular extension, with/without an identifiable index lesion)
* Cervical nodal disease with a synchronous index lesion or previously resected cutaneous primary tumour (\<5 years) within the corresponding nodal drainage and a mucosal primary has been excluded with at least a CT +/- MRI and panendoscopy\* \*For cervical nodal disease to be eligible there must be at least one of the following criteria:

  * \> 2 nodes
  * largest node \> 3 cm
  * Extracapsular extension

Advanced Primary Disease (TNM 6th Edition 2002) (Appendix 1)

* T3-4 primary disease (cartilage, skeletal, muscle, bone involvement, \> 4 cm) of the head and neck including lip, nose and external auditory canal with or without nodal disease
* In transit metastases (metastases between the primary site and the adjoining nodal basin)

  * Age \> 18 years
  * Written informed consent
  * ECOG \<= 2
  * Absolute neutrophil count \> 1.5 X 10\^9/L, platelet count \> 100 X 10\^9/L, and haemoglobin \> 10 g/dL (pre-radiotherapy blood transfusion to elevate the haemoglobin \> 10 g/dL is permissible)
  * Calculated creatinine clearance (Cockcroft-Gault) \>= 40 mL/min
  * Available for follow-up for up to 5 years
  * Life expectancy greater than 6 months

Exclusion Criteria:

* Intercurrent illness that will interfere with either the chemotherapy or radiotherapy such as immunosuppression due to medication or medical condition
* Metastasis(es) below the clavicles
* Previous radical radiotherapy to the head and neck, excluding treatment of an early glottic cancer greater than or equal to 2 years ago and superficial radiotherapy to cutaneous SCC or Basal cell carcinoma
* High risk for poor compliance with therapy or follow-up as assessed by investigator
* Pregnant or lactating women
* Patients with prior cancers, except: those diagnosed \> 5 years ago with no evidence of disease recurrence and clinical expectation of recurrence of less than 5%; or successfully treated Level 1 cutaneous melanomas or early glottic cancer \> 2 years ago; or non-melanoma skin cancer; or carcinoma in situ of the cervix.
* Low risk cervical nodal disease\* without advanced primary disease

  \*Low risk cervical nodal disease is defined as the presence of all of the following criteria:
* single nodal metastasis
* greater then or equal to 3cm,
* no extracapsular extension