Intermediate Stage (TNM Stage II/Stage III) Head and Neck Squamous Cell Carcinoma
Conditions
Interventions
Trade Name: Erbitux
Product Name: Cetuximab
Product Code: Erbitux
Pharmaceutical Form: Solution for infusion
Other descriptive name: Cetuximab
Concentration unit: mg/ml milligram(s)/millilitre
Concent
Sponsors
Christie Hospital NHS Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • A histopathological diagnosis of head and neck squamous cell carcinoma • Head and neck subsites of oropharynx, larynx, hypopharynx • Requires radiotherapy as primary treatment • Stage II (T2N0) • Stage III (T1N1, T2N1, T3N0) • WHO performance status 0-2 • Age = 16 and estimated life expectancy > 3 months • Adequate haematological function: Haemoglobin = 10g/dl; WBC = 3.0 x 109/l; ANC = 1.5 x 109/l; platelet count = 100,000/mm3 (prior transfusions for patients with low haemoglobin allowed) • Adequate liver function: total bilirubin = 1.5 x ULN; ALT, AST & ALP = 1.5 x ULN • Adequate renal function with serum urea & creatinine = 1.5 x ULN. • Women of child-bearing potential should have a negative pregnancy test prior to study entry • Women and men of child-bearing potential should be using an adequate contraception method, which must be continued for 3 months after completion of chemotherapy • Capable of giving informed consent • Following types of interventions are allowed: o Neck dissection for suspicious or clinically involved lymph nodes o Tumour excision for diagnostic purpose eg. Tonsillectomy Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • Head and neck sub-sites of oral cavity, sinus, nasopharynx, salivary glands, ear • Low risk Stage II o Laryngeal glottic carcinoma T2a • Previous surgical curative resection for primary tumour • Neck lymph nodes clinically or radiologically >2cm without neck dissection • Patients with metastatic disease • Previous radiotherapy within treatment field • Relative contraindication to radiotherapy • Previous administration of EGF monoclonal antibodies, EGFR signal transduction inhibitors or EGFR targeted therapy • History of previous malignancy (except cervical carcinoma in-situ treated by cone-biopsy/resection, non-metastatic basal cell carcinomas of the skin, any early stage (stage I) malignancy adequately resected for cure greater than 5 years previously) • Any disorder likely to impact compliance with the protocol • Pregnancy or breast feeding • Use of any experimental drugs (for any indication) in the previous 4 weeks
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess acute toxicity and tolerability of escalated radiotherapy dose with cetuximab;Secondary Objective: To assess late toxicity, response rate, loco-regional control, overall survival;Primary end point(s): To assess Acute Toxicity using CTCAE ver 3.0 | — |
Countries
United Kingdom
Outcome results
None listed