Trial document





This trial has been registered retrospectively.
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  DRKS00016654

Trial Description

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Title

Cervical lymph node involvement in dependence of tumor localization of oral squamos cell carcinoma - a retrospective study

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

Introduction: Cervical lymph node dissection is an important component of primary surgical therapy of oral malignancies. So far, little is known about the pathway of lymphogenic metastasis of oral squamous cell carcinoma in relation to the primary tumor localization. The knowledge about the aformentioned could contribute to a more precise surgical procedure of patients with oral squamous cell carcinoma. This study aimed to identify the lymph node involvement pathways within oral squamous cell carcinoma (OSCC) in relation to the localization of the primary tumor within the oral cavity.
Materials and Methods: In a retrospective single-center study patients with primary tumor resection and different forms of cervical lymph node dissection (ND) of OSCC in the period from 2013 to 2017 were examined. All patients received Computed Tomography (CT) or Magnetic resonance imaging (MRI) of the Head and Neck Region plus abdominal and plumonary CT for staging. The result of the histopathological examination and the anatomical descriptive allocation to levels depending on the localization of the tumor were examined. Patients with previous radiotherapy or chemotherapy have been excluded.
Results: A total of 146 patients with primary tumor resection and cervical lymph node dissection were examined. 26 % of all patients had a suprahomoyidal ND, 25 % a complete ND on both sides. The rate of cervical metastases is 28 %. 91 % of lymph node involvement is shown in levels 1 and 2. Level 1 shows 46 %, level 2 for 45 %, Level 3 7 %, level 4 2% of lymph node involvement. No further lymph node involvement was observed.
Conclusion: An overview of the affected lymph node levels depending on the primary localization of the tumor was derived from the study. The study serves as an indication to determine the extent of neck lymph node removal required.

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Brief Summary in Scientific Language

Oral squamous cell carcinoma is on the increase worldwide. The therapy consists of surgery, radiation and/or chemotherapy. In addition to tumor resection, cervical dissection is an important part of the primary surgical treatment of oral malignancies. This achieves better tumor control. Depending on the extent of the tumor and the results of staging, various forms of neck dissection are possible. This influences patient survival and quality of life. So far, little is known about the ways of lymphogenic metastasis of oral squamous cell carcinoma.
The aim of the study is to identify the lymph node involvement in oral squamous cell carcinoma depending on the localization of the primary tumor by histopathological examination. The results will be compared with data on the involvement of cervical lymph node levels (according to Robbins).
In a retrospective single-center study, patients with primary tumor resection of oral squamous cell carcinoma and concomitant neck dissection will be examined in the period from 01.01.2013 to 31.12.2017.
For this purpose, 10 regions of primary tumor localization will be identified and assigned. Depending on the histopathological examination and the anatomical descriptive allocation to levels, the lymph node metastases are examined and allocated according to the primary tumor site.
An overview of the affected lymph node levels as a function of the primary localization of the tumor can be derived from the examination.

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Organizational Data

  •   DRKS00016654
  •   2019/02/13
  •   [---]*
  •   yes
  •   Approved
  •   40/18, Ethikkommission des Fachbereichs Humanmedizin der Johann-Wolfgang-Goethe-Universität Frankfurt am Main
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Secondary IDs

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Health Condition or Problem studied

  •   C01 -  Malignant neoplasm of base of tongue
  •   C02 -  Malignant neoplasm of other and unspecified parts of tongue
  •   C03 -  Malignant neoplasm of gum
  •   C04 -  Malignant neoplasm of floor of mouth
  •   C05 -  Malignant neoplasm of palate
  •   C06 -  Malignant neoplasm of other and unspecified parts of mouth
  •   C07 -  Malignant neoplasm of parotid gland
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Interventions/Observational Groups

  •   Retrospective data analysis of patients with oral squamous cell carcinoma and neck dissection was conducted since 04/2018. 150 patients between 01.01.2013 and 31.12.2017 have been identified. Primary localization of tumor, cervical lymphnode involvement and type of neck dissection are recorded. Lymphnode involvement is recorded according to the primary localization of tumor.
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Characteristics

  •   Non-interventional
  •   Epidemiological study
  •   Single arm study
  •   Open (masking not used)
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  •   Uncontrolled/Single arm
  •   Diagnostic
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

Cervical lymphnode involvement in dependence of primary localization of oral squamous cell carcinoma (OSCC); retrospective data analysis beginning 04/2018

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Secondary Outcome

further clinical and epidemiological data: sex, age, TNM, type of neck dissection

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
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Recruitment

  •   Actual
  •   2018/04/01
  •   150
  •   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

Diagnosis of oral squamous cell carcinoma, primary tumor resection, neck dissection

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Exclusion Criteria

None

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Addresses

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    • Klinikum der Johann Wolfgang Goethe-Universität Frankfurt am Main
    • Theodor-Stern-Kai 7
    • 60590  Frankfurt am Main
    • Germany
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    • Klinik für Mund-, Kiefer- und Plastische Gesichtschirurgie, Goethe-Universität
    • Mr.  Prof. Dr. Dr. Dr.  Shahram  Ghanaati 
    • Theodor-Stern-Kai 7
    • 60486  Frankfurt
    • Germany
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    • Klinik für Mund-, Kiefer- und Plastische Gesichtschirurgie, Goethe-Universität
    • Mr.  Dr.  Philipp  Thönissen 
    • Theodor-Stern-Kai 7
    • 60486  Frankfurt
    • Germany
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Sources of Monetary or Material Support

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    • Klinik für Mund-, Kiefer- und Plastische Gesichtschirurgie, Goethe-Universität
    • Mr.  Prof. Dr. Dr. Dr.  Shahram  Ghanaati 
    • Theodor-Stern-Kai 7
    • 60486  Frankfurt
    • Germany
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Status

  •   Recruiting complete, follow-up continuing
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Trial Publications, Results and other Documents

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