Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
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  DRKS00005918

Trial Description

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Title

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

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

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.

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Brief Summary in Scientific Language

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.

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Organizational Data

  •   DRKS00005918
  •   2015/11/03
  •   2014/02/10
  •   yes
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Secondary IDs

  •   NCT02059668  (ClinicalTrials.gov)
  •   STR- HNprädBio-2013  (Technische Universität Dresden)
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Health Condition or Problem studied

  •   Head and Neck Cancer
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Interventions/Observational Groups

  •   Biological: Biomarker analyses head & neck cancer tissue, blood specimen
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Characteristics

  •   Non-interventional
  •   Observational study
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  •   N/A
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Primary Outcome

- local recurrence free survival; time frame: after 2 years

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Secondary Outcome

- disease-free survival; time frame: after 2 years
- metastases-free survival; time frame: after 2 years
- overall survival; time frame: after 2 years

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

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Recruitment

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  •   2014/03/31
  •   480
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional 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)

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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

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Addresses

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    • Technische Universität Dresden
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    • Dresden University of Technology, Universital Hospital Carl Gustav Carus, Department of Radiation Therapy and Radiation Oncology
    • Michael Baumann, Prof. 
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    • Michael Baumann, Prof. 
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Sources of Monetary or Material Support

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    • Bitte wenden Sie sich an den Sponsor / Please refer to primary sponsor
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Status

  •   Recruiting planned
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Trial Publications, Results and other Documents

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The parameters in ClinicalTrials.gov and DRKS are not identical. Therefore the data import from ClinicalTrials.gov required adjustments. For full details please see the DRKS FAQs .
  •   2
  •   2014/02/23
* This entry means the parameter is not applicable or has not been set.