Trial document





This trial has been registered retrospectively.
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  DRKS00003830

Trial Description

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Title

Evaluation of 18F-MISO-PET detectable changes in proliferation and dispersion of hypoxic subvolume in head and neck cancer in patients undergoing radio(chemo)therapy

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Trial Acronym

F-MISO-PET

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URL of the Trial

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Brief Summary in Lay Language

Tumor hypoxia is a common characteristic in squamous cell carcinoma of the Head and Neck area. Tumor hypoxia correlated with poorer response to treatment in the context of radiotherapy. The aim is to detect the tumor hypoxia and its change over time during treatment.

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Brief Summary in Scientific Language

Evaluation of 18F-MISO-PET detectable changes in proliferation and dispersion of hypoxic subvolume in head and neck cancer in patients undergoing radio(chemo)therapy

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Organizational Data

  •   DRKS00003830
  •   2015/08/20
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  •   yes
  •   Approved
  •   68/08, Ethik-Kommission der Albert-Ludwigs-Universität Freiburg
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Secondary IDs

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Health Condition or Problem studied

  •   Squamous cell carcinoma of the head and neck
  •   C01 -  Malignant neoplasm of base of tongue
  •   C04 -  Malignant neoplasm of floor of mouth
  •   C09 -  Malignant neoplasm of tonsil
  •   C10 -  Malignant neoplasm of oropharynx
  •   C13 -  Malignant neoplasm of hypopharynx
  •   C32 -  Malignant neoplasm of larynx
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Interventions/Observational Groups

  •   33 patients should have a combined PET before the start of therapy. The changes of hypoxic subvolumes in the tumors will be recorded in further 2 PET in therapy week 2 and 5.
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Characteristics

  •   Interventional
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  •   Single arm study
  •   Open (masking not used)
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  •   Uncontrolled/Single arm
  •   Treatment
  •   Single (group)
  •   II
  •   N/A
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Primary Outcome

- changes in PET detected tumor hypoxia in week 0, week 2 and week 5 of radiochemotherapy by evaluation of SUV and hypoxic subvolumes
- changes in MRT detected perfusion, diffusion and oxygenation in week 0, week 2 and week 5 of radiochemotherapy by evaluation of ADC, ktrans

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Secondary Outcome

- Clinical Follow-ups in addition to radiographic diagnostic to determine overall survival, local tumour control, distant metastasis; point of time: every 3 months in the first 2 years and controls in form of routine follow ups for 5 years
- comparison of 3-Tesla-MRI and FMISO-PET/CT scans to establish methods for defining hypoxic subvolumes

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2010/02/03
  •   33
  •   Monocenter trial
  •   National
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Inclusion Criteria

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

Histo - or cytologically secured squamous cell carcinoma of the oral cavity, hypopharynx or larynx
• Stage III / IV (M0)
• ECOG performance status 0 or 1
• Two-dimensionally measurable tumor> = 2cm in at least one dimension
• Age> = 18 years
Adequate hematologic function • (Hb> 9 g / dl, platelets> = 100X 10 9 / l, ANC> = 1.5 X 10 9 / L)
• Adequate renal function (creatinine - clearance> = 50 ml / min)
• Adequate liver function (AST, ALT and total bilirubin <= 2X ULN)
• Adequate metabolic function (including Mg> = LLN)
• Written consent

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Exclusion Criteria

Previous anti-EGFR antibody therapy or treatment with small molecule tyrosine kinase inhibitors
• Previous surgery, chemotherapy or radiation for in the relevant study malignancies
• Prophylactic tracheostomy
• Other known clinically significant diseases (cardiovascular, pulmonary, infections such as HIV, HCV, HBV, ...)
• Pregnant or lactating women
• To provide each type of disability, which affects the compliance or ability of the patient, written consent

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Addresses

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    • Klinik für Strahlenheilkunde, Freiburg
    • Ms.  Prof. Dr. med.  A.-L.  Grosu 
    • Robert-Koch-Str. 3
    • 79106  Freiburg
    • Germany
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    • Klinik für Strahlenheilkunde
    • Ms.  Dr.  Nicole  Wiedenmann 
    • Robert-Koch-Str. 3
    • 79106  Freiburg
    • Germany
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    • Klinik für Strahlenheilkunde
    • Ms.  Dr.  Nicole  Wiedenmann 
    • Robert-Koch-Str. 3
    • 79106  Freiburg
    • Germany
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Sources of Monetary or Material Support

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    • Klinik für Strahlenheilkunde, Freiburg
    • Ms.  Prof. Dr. med.  A.-L.  Grosu 
    • Robert-Koch-Str. 3
    • 79106  Freiburg
    • Germany
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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