Trial document





This trial has been registered retrospectively.
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  DRKS00006868

Trial Description

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Title

Is there a change of differentiation in recurrences of oral squamous cell carcinoma (OSCC)? Recurrence rate and grading-shift.

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Trial Acronym

[---]*

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URL of the Trial

[---]*

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Brief Summary in Lay Language

Purpose of the study is the rate of recurrence in OSCC after initial surgical treatment in the Department of Oral and Maxillofacial Surgery University Medical Center Freiburg. Moreover, the influence of tumorsize, cervical lymphnode stage, and differentiation of the primary tumor on recurrences were analyzed.

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Brief Summary in Scientific Language

Few information are available whether recurrences of oral squamous cell carcinoma (OSCC) show a different histopathological grade than the primary tumor and whether postoperative radiotherapy (PORT) influences the grade of differentiation in case of recurrence. The objective of this study was the evaluation of the recurrence rate and the change in differentiation of OSCC on the long-term.

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Organizational Data

  •   DRKS00006868
  •   2014/11/27
  •   [---]*
  •   yes
  •   Approved
  •   431/13, Ethik-Kommission der Albert-Ludwigs-Universität Freiburg
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Secondary IDs

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

  •   C06.9 -  Malignant neoplasm: Mouth, unspecified
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Interventions/Observational Groups

  •   Retrospektive analysis of recurrences and change of tumor differentiation in surgically treated OSCC cases.
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Characteristics

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

Time to Recurrence

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Secondary Outcome

therapy of the primary tumour and differetiation of the recurrence

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2013/10/15
  •   429
  •   Monocenter trial
  •   National
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Inclusion Criteria

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

1. surgical treatment from January 1st 2000 to June 30th 2013
2. patients with primary OSCC
3. initial surgical therapy
4. adjuvant radiotherapy

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Exclusion Criteria

Patients were excluded in case of 1. malignancies other than OSCC, 2. extraoral location of tumor 3. primary non-surgical therapy (radio-chemotherapy), 4. secondary OSCC or CUP syndrome

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Addresses

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    • Uniklinik FreiburgKlinik für MKG Chirurgie
    • Mr.  Michael  Ermer 
    • Hugstetter Str. 55
    • 79106  Freiburg
    • Germany
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    • Uniklinik FreiburgKlinik für MKG Chirurgie
    • Mr.  Michael  Ermer 
    • Hugstetter Str. 55
    • 79106  Freiburg
    • Germany
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    • Uniklinik FreiburgKlinik für MKG Chirurgie
    • Mr.  Michael  Ermer 
    • Hugstetter Str. 55
    • 79106  Freiburg
    • Germany
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Sources of Monetary or Material Support

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    • Klinik für MKG Chirurgie
    • Mr.  Michael  Ermer 
    • Hugstetter Str. 55
    • 79106  Freiburg
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2013/12/31
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Trial Publications, Results and other Documents

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