Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 5:37 PM
Ignite Modification Date:
2025-12-24 @ 5:37 PM
NCT ID:
NCT02059668
Brief Summary:
The aim of this clinical research project is to validate the prognostic impact of potential biomarkers on loco-regional control of locally advanced head and neck cancer after definitive or adjuvant radiochemotherapy. The treatment is equal to the standard of care.
Potential biomarkers from a previous retrospective study will be validated in this prospective study.
Detailed Description:
Objectives:
Primary: Evaluation of local-regional recurrence- free survival after two years of patients with locally advanced head and neck cancer who received definitive or adjuvant radiochemotherapy.
Secondary: Evaluation of disease-free -survival, metastases-free and overall survival after two years, of patients with locally advanced head and neck cancer.
Outline: This is a multicenter observational study. The treatment is based on the center specific standard of care. The total dose will be between 69 and 73 Gy (definitive treatment) and 63 and 66 Gy (adjuvant treatment), the chemotherapy will be cisplatin- based.
The aim of the analysis is to validate the prognostic impact of potential biomarkers on loco-regional control. This will lead to the definition of risk groups and stratification of patients and will help to individualize radiotherapy prescription in future trials.
Study:
NCT02059668
Study Brief:
Protocol Section:
NCT02059668