Squamous Cell Carcinoma or the oroplharynx, Larynx or Hypopharynx suitable for radical primary treatment with chemoradiotherapy
Conditions
Interventions
Trade Name: Cisplatin
Product Name: Cispltin
Pharmaceutical Form: Concentrate for solution for infusion
Trade Name: Erbitux
Pharmaceutical Form: Solution for infusion
Sponsors
Royal Wolverhampton Hospitals Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients with Squamous Cell Carcinoma of the Oropharynx, Larynx and Hypopharynx suitable for radical primary treatment with chemoradiotherapy in the opinion of treating clinical oncologist Radiotherapy Schedule prescibed to be 70Gy in 35 fractions 5 fraction per week TNM Stage 3 or 4 ( 7th editiion) Patient considered sutable to recieve cisplatin therapy in the opinion of treating clinical oncologist Age 18-70 Expected survival greater than 6 months• Patient able to give informed consent •Haematological Parameters at study entry: - • Blood cell counts: Absolute neutrophils > 1.5 x 109/L Platelets > 100 x109/L Haemoglobin > 12 g/dl • Renal function: EDTA-based glomelular filtration rate of > 50 mL/min or a cockcroft gault calculated GFR of > 60 mL/min. • Hepatic functions: Serum bilirubin within normal limits. or AST or ALT =65 years) F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Palliative Radiotherapy Accelerated Radiotherapy Prior Radical Surgery for Primary Squamous Cell Carcinoma of the Head and Neck (neck disection is allowed) Treatment within the last 4 weeks with any investigational drug. Presence of distant metastases. Evidence of uncontrolled infection. Mental condition rendering the subject unable to understand the nature, scope and possible consequences of the study. Neoadjuvant chemotherapy for squamous cell carcinoma of the head and neck prior to study entry. Preexisiting peripheral sensory neuropathy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the direct costs of erbitux and radiotherapy versus Cisplatin and radiothearpy RT taking in to account drug costs, clinical management and the costs of managing treatment related toxicity. The primary outcome measure of the study is mean overall cost (in pounds sterling) of total therapy from randomization to the end of the late phase of the study follow up in both arms of the study. ;Secondary Objective: To document unplanned gaps in both radiotherapy and chemotherapy treatment delivery in both treatment arms To document inpatient hospital admission rates in both treatment arms To assess impact of treatment of Quality of Life To assess median overall cost (in pounds sterling) of total therapy from randomization to the end of the late phase of the study follow up in both arms of the study. ;Primary end point(s): The primary outcome measure of the study is mean overall cost (in pounds sterling) of total therapy from randomization to the end of the late phase of the study follow up in both arms of the study. | — |
Countries
United Kingdom
Outcome results
None listed