Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 2:14 PM
Ignite Modification Date:
2025-12-24 @ 2:14 PM
NCT ID:
NCT00193895
Eligibility Criteria:
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00193895
Study Brief:
Protocol Section:
NCT00193895