Observational Study on Biomarkers in Head and Neck Cancer (HNprädBio)
NCT ID: NCT02059668
Last Updated: 2022-08-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
588 participants
OBSERVATIONAL
2014-03-31
2022-06-30
Brief Summary
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Potential biomarkers from a previous retrospective study will be validated in this prospective study.
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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.
Biomarker analyses head & neck cancer tissue, blood specimen
For biomarker analyses, tumor tissues from previous biopsies and surgery and blood specimens taken during treatment at the treating institution will be used.
Interventions
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Biomarker analyses head & neck cancer tissue, blood specimen
For biomarker analyses, tumor tissues from previous biopsies and surgery and blood specimens taken during treatment at the treating institution will be used.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Technische Universität Dresden
OTHER
Responsible Party
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Mechthild Krause
Prof. Dr. Mechthild Krause
Principal Investigators
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Mechthild Krause, Prof.
Role: PRINCIPAL_INVESTIGATOR
Dresden University of Technology, Universital Hospital Carl Gustav Carus, Department of Radiation Therapy and Radiation Oncology
Locations
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Prof. Anca-Ligia Grosu
Freiburg im Breisgau, Baden-Wurttemberg, Germany
Prof. Jürgen Debus
Heidelberg, Baden-Wurttemberg, Germany
Prof. Daniel Zips
Tübingen, Baden-Wurttemberg, Germany
Prof. Claus Belka
München, Bavaria, Germany
Prof. Stephanie Combs
München, Bavaria, Germany
Prof. Claus Rödel
Frankfurt am Main, Hesse, Germany
Prof. Martin Stuschke
Essen, North Rhine-Westphalia, Germany
Prof. Mechthild Krause
Dresden, Saxony, Germany
Prof. Volker Budach
Berlin, , Germany
Praxis für Strahlentherapie im Krankenhaus Dresden - Friedrichstadt
Dresden, , Germany
Countries
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References
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Niu M, Combs SE, Linge A, Krause M, Baumann M, Lohaus F, Ebert N, Tinhofer I, Budach V, von der Grun J, Rodel F, Grosu AL, Multhoff G. Comparison of the composition of lymphocyte subpopulations in non-relapse and relapse patients with squamous cell carcinoma of the head and neck before, during radiochemotherapy and in the follow-up period: a multicenter prospective study of the German Cancer Consortium Radiation Oncology Group (DKTK-ROG). Radiat Oncol. 2021 Jul 31;16(1):141. doi: 10.1186/s13014-021-01868-5.
Other Identifiers
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STR- HNprädBio-2013
Identifier Type: -
Identifier Source: org_study_id
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