Trial document




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  DRKS00006007

Trial Description

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Title

Tumor hypoxia measured with F-MISO-PET in the course of irradiation of head and neck cancer: adoption of the method into clinical routine and evaluation of the data

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Trial Acronym

F-MISO-R

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URL of the Trial

[---]*

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Brief Summary in Lay Language

Locally advanced tumours of the head and neck region are usually treated with radiotherapy in combination with chemotherapy. By performing an additional imaging modality (FMISO-PET) before radiotherapy and during the beginning of the treatment it is possible to obtain additional informations about the aggressiveness of the tumour (existence of areas that are low in oxygen, so called hypoxia). In a previous study at our institution it was shown that patients with unfavourable findings at the second FMISO-PET investigation (high amount of hypoxia) had a very poor prognosis while patients without residual hypoxia could mostly be cured. Due to the high prognostic impact of the FMISO-PET we want to offer it to all eligible patients. Furthermore we plan additional blood analysis at both imaging timepoints. By this means we hope to identify novel blood-markers that correlate to the FMISO-PET predication.

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Brief Summary in Scientific Language

Locally advanced head and neck squamous cell carcinomas (HNSCC) are mostly treated with primary radio(chemo-)therapy. Due to the advanced tumour stages more than half of the patients present local recurrences during follow-up. In a previous study at our institution it was shown that patients could be risk-stratified according to residual tumour hypoxia in the 18-F-MISO-PET during therapy. Patients with eminent residual hypoxia presented a very unfavourable local progression free survival compared to patients without residual hypoxia. Hence we want to offer the FMISO-PET to all eligible patients as an enhanced diagnostic standard. Furthermore we plan additional blood analysis at both imaging timepoints. Blood examinations will be performed for hypoxia specific proteins and cytokines that might correlate to FMISO-PET findings.

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Organizational Data

  •   DRKS00006007
  •   2014/07/14
  •   [---]*
  •   yes
  •   Approved
  •   EK 190012014, Ethikkommission der Medizinischen Fakultät der Technischen Universität Dresden
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   C10 -  Malignant neoplasm of oropharynx
  •   C13 -  Malignant neoplasm of hypopharynx
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Interventions/Observational Groups

  •   18F FMISO PET before radiotherapy and after 2 weeks radiotherapy and additional blood analysis at both imaging timepoints
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Characteristics

  •   Non-interventional
  •   Other
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Prognosis
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

Local progression free survival in case of residual hypoxia (measured as TBRmax > 1.9) after 20Gy radio-chemotherapy. This is measured two years after completion of treatment, a so-called 2-year local progression-free survival. The data of residual hypoxic versus non-hypoxic patients are evaluated according to the Cox proportional hazard model as a comparison of the survival curves.

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Secondary Outcome

Further evaluation of oncologic parameters: Overall survival, local control, progression free survival. These are checked after 2 and 5 years. Furthermore measure quality of life and correlation with dosimetric parameters. To measure quality of life, the established EORTC-QLQ-C30 and HN35 sheets are used. The sheets are handed out to the patients before therapy, and twice shortly after the end of treatment. Subsequently once a year to five years after the end of treatment. In addition a correlation of hypoxia markers from blood samples to be taken and FMISO PET parameters and oncological parameters takes place.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2014/09/09
  •   80
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   70   Years
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Additional Inclusion Criteria

• age 18-70 years
• inoperable histological confirmed head and neck cancer (squamous cell carcinoma of the pharynx, oral cavity and supraglottis)
• general condition WHO 0-2
• tumor volume and location permit curative radiotherapy

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Exclusion Criteria

• distant metastases
• previous irradation in the head and neck region
• second carcinoma except T1 skin cancer and in-Situ-carcinoma of the cervix uteri
• pregnancy
• lack of understanding or lack of cooperation

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Addresses

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    • Universitätsklinikum DresdenKlinik für Strahlentherapie und Radioonkologie
    • Ms.  Prof. Dr. med.  Mechthild  Krause 
    • Fetscherstraße 74
    • 01307  Dresden
    • Germany
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    • Universitätsklinikum Dresden, Klinik für Strahlentherapie und Radioonkologie
    • Ms.  Prof. Dr. med.  Mechthild  Krause 
    • Fetscherstraße 74
    • 01307  Dresden
    • Germany
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    • Universitätsklinikum Dresden, Klinik und Poliklinik für Strahlentherapie und Radioonkologie, Klinisches Studienzentrum
    • Ms.  Annett  Klöber 
    • Fetscherstraße 74
    • 01307  Dresden
    • Germany
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Sources of Monetary or Material Support

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    • Universitätsklinikum DresdenKlinik für Strahlentherapie und Radioonkologie
    • Ms.  Prof. Dr. med.  Mechthild  Krause 
    • Fetscherstraße 74
    • 01307  Dresden
    • Germany
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Status

  •   Recruiting ongoing
  •   [---]*
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.