Squamous cell carcinomas of the Head and Neck treated with primary radiotherapy/kemoradiotherapy and randomized to the IMP in question (zalutumumab). MedDRA version: 9.1 Level: LLT Classification code 10060121 Term: Squamous cell carcinoma of head and neck
Conditions
Interventions
Product Name: zalutumumab (HuMax-EGFr)
Product Code: (HuMax-EGFr)
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: zalutumumab
CAS Number: 667901-13-5
Current Sponsor co
Sponsors
Danish Head and Neck Cancer Group
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Histologically proven squamous cell carcinoma of the head and neck. Site: cavum oris, larynx, oropharynx or hypopharynx. All T-stages, all N-stages except all stage I larynx and stage II glottic larynx. Primary tumours with indication for curative intended primary radiotherapy. Age>18 years. WHO performance 0-2. Fertile women must use safe contraception. Informed concent according to local or national laws. The patient is expected to be able to follow treatment, follow-up and required testes and examinations. 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: Rhinoparynx carcinomas and tumours with unknown origin. Distant metastases. Previous or current malignant disease that could affect current treatment or the prognosis. Previous or current treatment with EGFr-inhibitors. Previous or current surgery, chemotherapy or radiotherapy for malignant disease in the head and neck region. Psycological , familiary, sociological or or geografical relations that could compromize the ability of the patient to follow the protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The main objective is (in an oben randomized trial) to evaluate whether concomitant treatment with curative intended radiotherapy and zalutumumab is better than curative intended radiotherapy alone in patients with squamous cell carcinoma of the head and neck. ;Secondary Objective: The secondary objective is to evaluate the feasibility and tolerability of concomitant treatment with curative intended radiotherapy and zalutumumab. ;Primary end point(s): Loco-regional control at 5 years after radiotherapy. T-site control at 5 years after radiotherapy. Disease-specific survival at 5 years after radiotherapy. Overall survival at 5 years after radiotherapy. Acute and late morbidity. | — |
Countries
Denmark
Outcome results
None listed