Observational Study on Biomarkers in Head and Neck Cancer (HNprädBio) (HNprädBio)
Observational Study on Biomarkers in Head and Neck Cancer
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.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Berlin, Germany, 10117
- Prof. Volker Budach
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Dresden, Germany, 01067
- Praxis für Strahlentherapie im Krankenhaus Dresden - Friedrichstadt
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Baden-Wuerttemberg
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Freiburg, Baden-Wuerttemberg, Germany, 79106
- Prof. Anca-Ligia Grosu
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Heidelberg, Baden-Wuerttemberg, Germany, 69120
- Prof. Jürgen Debus
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Tübingen, Baden-Wuerttemberg, Germany, 72016
- Prof. Daniel Zips
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Bavaria
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München, Bavaria, Germany, 81377
- Prof. Claus Belka
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München, Bavaria, Germany, 81675
- Prof. Stephanie Combs
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Hesse
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Frankfurt, Hesse, Germany, 60590
- Prof. Claus Rödel
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North Rhine-Westphalia
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Essen, North Rhine-Westphalia, Germany, 45147
- Prof. Martin Stuschke
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Saxony
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Dresden, Saxony, Germany, 01307
- Prof. Mechthild Krause
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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Biomarker analyses head & neck cancer tissue, blood specimen
Validation of prognostic biomarkers for local tumor control in definitive and adjuvant treatment of head and neck cancer.
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For biomarker analyses, tumor tissues from previous biopsies and surgery and blood specimens taken during treatment at the treating institution will be used.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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local recurrence free survival
Time Frame: after 2 years
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after 2 years
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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disease-free survival
Time Frame: after 2 years
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after 2 years
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metastases-free survival
Time Frame: after 2 years
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after 2 years
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overall survival
Time Frame: after 2 years
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after 2 years
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Mechthild Krause, Prof., Dresden University of Technology, Universital Hospital Carl Gustav Carus, Department of Radiation Therapy and Radiation Oncology
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- STR- HNprädBio-2013
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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