Observational Study on Biomarkers in Head and Neck Cancer (HNprädBio)

Study Overview
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Brief Summary
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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
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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.

Official Title
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Observational Study on Biomarkers in Head and Neck Cancer

Conditions
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Head and Neck Cancer

Intervention / Treatment
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* Biological: Biomarker analyses head & neck cancer tissue, blood specimen


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Primary radiochemotherapy: Patients with locally advanced squamous cell carcinoma of the oral cavity, oropharynx or hypopharynx Stage III or IV without distant metastases Patient is able to participate in regular tumor follow-up care planned irradiation dose 69-72 Gy planned overall treatment time 38-54 days written informed consent of the patient general condition according to WHO 0-2 planned simultaneous chemotherapy with cisplatin (cumulative planned total dose minimum 180 mg/m2 body surface, divided in several separately doses) Adjuvant radiochemotherapy: Patients with locally advanced squamous cell carcinoma of the oral cavity, oropharynx or hypopharynx surgery, existence of one or more of the following risk factors for local recurrence: extracapsular growth of a minimum of one lymph node metastasis R1 resection pT4 tumor and more than 3 affected lymph nodes Patient is able to participate in regular tumor follow-up care planned irradiation dose 63-66 Gy planned overall treatment time 44-48 days planned simultaneous chemotherapy with cisplatin (cumulative planned total dose minimum 200 mg/m2 body surface, divided in several separately doses) written informed consent of the patient general condition according to WHO 0-2 time since last surgery <56 days (8 weeks) Exclusion Criteria: Primary radiochemotherapy: distant metastasis contraindication against a cisplatin-based chemotherapy planned total irradiation dose <69 Gy and >72 Gy planned overall treatment time >54 days or <38 days Patient is incapable of giving consent previous radiotherapy in the head and neck area, if there is a risk for overlapping of the irradiation areas other tumor diseases, which currently need a treatment or probably within the next two years or which influence the prognosis of the patient tumor-independent diseases or conditions which reduce the survival probability of the patient to <2 years or which affect the follow-up over 2 years no written informed consent induction chemotherapy pregnancy or lactation Adjuvant radiochemotherapy: distant metastasis contraindication against a cisplatin-based chemotherapy planned total irradiation dose < 63 Gy or > 66 Gy planned overall treatment time > 48 days or < 44 day Patient is incapable of giving consent previous radiotherapy in the head and neck area, if there is a risk for overlapping of the irradiation areas other tumor diseases, which currently need a treatment or probably within the next two years or which influence the prognosis of the patient tumor-independent diseases or conditions which reduce the survival probability of the patient to <2 years or which affect the follow-up over 2 years no written informed consent pregnancy or lactation

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Biomarker analyses head & neck cancer tissue, blood specimen<br>Validation of prognostic biomarkers for local tumor control in definitive and adjuvant treatment of head and neck cancer. | Biological: Biomarker analyses head & neck cancer tissue, blood specimen<br>* For biomarker analyses, tumor tissues from previous biopsies and surgery and blood specimens taken during treatment at the treating institution will be used.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| local recurrence free survival |  | after 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| disease-free survival |  | after 2 years | 
| metastases-free survival |  | after 2 years | 
| overall survival |  | after 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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locally advanced head and neck cancer, biomarkers, definitive treatment, adjuvant treatment, radiochemotherapy