Status:
COMPLETED
Post-operative Concurrent Chemo-radiotherapy Versus Post-operative Radiotherapy for Cancer of the Head and Neck
Lead Sponsor:
Trans Tasman Radiation Oncology Group
Collaborating Sponsors:
Princess Alexandra Hospital, Brisbane, Australia
The Royal Australian and New Zealand College of Radiologists
Conditions:
Skin Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The primary objective of the trial is to determine, in patients who have undergone surgery with curative intent for high-risk CSCC of the head and neck, whether there is a difference in time to loco-r...
Detailed Description
Two in every 3 Australians will be affected by skin cancer over their lifetime. The prevalence of skin cancer will continue to increase due to the ageing population and represents a significant proble...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 31 2016
Estimated Enrollment :
321 Patients enrolled
Trial Details
Trial ID
NCT00193895
Start Date
April 1 2005
End Date
March 31 2016
Last Update
April 6 2018
Active Locations (21)
Enter a location and click search to find clinical trials sorted by distance.
1
Liverpool Hospital
Liverpool, New South Wales, Australia, 1871
2
Calvary Mater Newcastle
Newcastle, New South Wales, Australia, 2298
3
Royal North Shore Hospital
St Leonards, New South Wales, Australia, 2065
4
Royal Prince Alfred Hospital
Sydney, New South Wales, Australia, 2050