Stage III and IV head and neck squamous cell cancer (HNSCC) without radiographic signs of distant metastases aimed for radiotherapy with curative intent MedDRA version: 14.1 Level: PT Classification code 10071536 Term: Head and neck cancer stage IV System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 14.1 Level: PT Classification code 10071537 Term: Head and neck cancer stage III System Organ Class: 10029104 - Neoplasms benign, mali
Conditions
Interventions
Trade Name: Erbitux
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: CETUXIMAB
CAS Number: 205923-56-4
Concentration unit: mg/m2 milligram(s)/square meter
Concentration type: equal
Conc
Sponsors
Department of Oncology, Skåne University Hospital Lund
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.The patient must be over 18 years old. 2.Histologically or cytologically confirmed HNSCC of the oropharynx, hypopharynx, larynx or of the oral cavity aimed for unimodal treatment with radiotherapy with curative intent. 3.Tumour stage III and IV according to the UICC TNM classification, but with no evidence of distant metastases beyond the regional nodes in the neck. 4.WHO/ECOG performance status 0-2 5.The patient must be expected to withstand radiotherapy combined with cisplatin or cetuximab. 6.The patient must be able to understand the information about the treatment and give a written informed consent to participate in the trial. 7.Adequate follow-up study must be possible; this will exclude a patient who is uncooperative. 8.Adequate renal function, creatinine clearance > 50 mL/min/1.73 estimated according to local practise at each study centre 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 400 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 218
Exclusion criteria
Exclusion criteria: 1.Previous malignant disease in the head and neck region, with exception for basal cell carcinoma or curatively treated squamous cell carcinoma of the skin with follow-up time of at least 3 years. 2.Concomitant or previous malignancies. Exceptions are adequately treated basal cell carcinoma of the skin or in situ carcinoma of the cervix uteri, or other previous malignancy with a disease-free interval of at least 5 years. 3.Two or more synchronous primary HNSCC at time of diagnosis 4.Co-existing disease prejudicing survival (expected survival >6 months). 5.Absolute neutrophil count (ANC) 1.5 times upper limit of normal (ULN) 8. Aspartate aminotransferase (ASAT) or alanine aminotransferase (ALAT) >3 times ULN 9. Pregnancy or lactation 10. Allergy to study drug or to the excipients in their formulation. 11. Peripheral neuropathy > grade 2 according to CTCAE v4.0, grade 2 = moderate symptoms limiting instrumental ADL) 12. Hearing loss / tinnitus is a relative exclusion criteria; 13. Severe cardiac illness
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To study whether overall survival is improved by treatment with radiotherapy + cetuximab compared to treatment with radio radiotherapy + cisplatin in the treatment of patients with locally advanced (stage III-IV) head and neck squamous cell carcinoma (HNSCC). ;Secondary Objective: •To study whether local control is enhanced with dose-escalated radiotherapy + cetuximab/cisplatin compared to treatment with standard-dose radiotherapy + cetuximab/cisplatin in locally advanced (T3 and T4) tumours •To describe early and late side effects of the treatment arms •To compare local and regional tumour control between the treatment arms •To determine pattern of failure •To evaluate quality of life •To determine if HPV and p16 positivity can consist a prognostic marker •To compare normal tissue sparing and normal tissue complications with different treatment techniques (3D-CRT vs. IMRT/VMAT/HTT) and radiotherapy only vs. radiochemotherapy by comparison with the results from the first ARTSCAN study •To make a health economic comparison between treatment with radiotherapy and cisplatin and treatment with radiotherapy and cetuximab •To find biomarkers that can guide therapy decisions ;Primary end point(s): Overall survival (OS). ;Timepoint(s) of evaluation of this end point: Follow up by the protocol ends at five years after end of treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): •Differences in local control between treatment with dose-escalated radiotherapy + cetuximab/cisplatin compared to treatment with standard-dose radiotherapy + cetuximab/cisplatin in locally advanced (T3 and T4) tumours •Early and late side effects •Local and regional tumour control •Pattern of failure •Quality of life •Prognostic value of HPV and p16 positivity •Normal tissue sparing and normal tissue complications •Cost-utility analysis •Exploratory, biomarker investigations (separate informed consent required) ;Timepoint(s) of evaluation of this end point: Five years after end of treatment | — |
Countries
Sweden
Contacts
Public ContactCoordinating investigator
Maria Gebre-Medhin
Outcome results
None listed