None listed
Conditions
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-regional relapse between patients treated with post-operative concurrent chemo-radiotherapy ,consisting of Carboplatin, and post-operative radiotherapy alone. The target sample size for the trial is 266 patients and will take 3-4 years to accrue, based on an anticipated accrual of 80 patients/year. A further 2 years follow up is required.
Interventions
Arm 2: Radiotherapy 60Gy or 66Gy in 30-33 fractions, 5 times a week, over 5-5.5 weeks. Plus, Carboplatin intravenously weekly on either day 1, 2 or 3 of radiation with a max of six doses. Dose of carboplatin is calcualted by a formula that changes the value for each patient. Formula is glomerular filtration rate + 25 x target area under the concentration curve (AUC).
Sponsors
Trans Tasman Radiation Oncology Group (TROG)
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Histologically proven Squamous Cell Carcinoma 2. Complete macroscpoic resection of all known disease with or withour microscpoic positive margins. Surgery may consist of one or more of the following:a)Resection of the primary lesion; b) Any type of parotidectomy (superficial, total, partial, etc.); c) Any type of neck dissection(s) 3. High risk feature(s); high risk nodal disease and/or advanced primary disease: a) High Risk Nodal Disease Intra-parotid nodal disease (any number or size, with/without extracapsular extension, with/without an identifiable index lesion) b) 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 Computed Tomography (CT) +/- Magnetic Resonance Imaging (MRI) and panendoscopy* * For cervical nodal disease to be eligible there must be at least one of the following criteria: (i) > 2 nodes (ii) largest node > 3cm (iii) Extracapsular extension c) Advanced Primary Disease (Tumor, Node, Metastasis (TNM) 6th Edition 2002) (Appendix 1) T3-4 primary disease (cartilage, skeletal, muscle, bone involvement, >4cm) of the head and neck including lip, nose and external auditory canal with or without nodal disease d) In transit metastases (metastases between the primary site and the adjoining nodal basin) 4. Age >18 years 5. Written informed consent 6. Eastern Cooperative Oncology Group (ECOG) < 2 7. Absolute neutrophil count > 1.5 X 109/L, platelet count > 100 X 109/L, and haemoglobin > 10g/dL (pre-radiotherapy blood transfusion to elevate the haemoglobin > 10g/dL is permissible) 8. Calculated creatinine clearance (Cockcroft-Gault) >40mL/min 9. Available for follow-up for up to 5 years 10. Life expectancy greater than 6 months.
Exclusion criteria
1. Intercurrent illness that will interfere with either the chemotherapy or radiotherapy such as immunosuppression due to medication or medical condition 2. Metastasis(es) below the clavicle 3. Previous radical radiotherapy to the head and neck, excluding treatment of an early glottic cancer > 2 years ago and superficial radiotherapy to cutaneous Squamous Cell Carcinoma (SCC) or basal cell carcinoma 4. High risk for poor compliance with therapy or follow-up as assessed by investigator 5. Pregnant or lactating women 6. 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. 7. 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; (i) single nodal metastasis, (ii) < 3 cm, (iii) no extracapsular extension.
Outcome results
None listed