Trial document




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  DRKS00009255

Trial Description

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Title

Prospective study of the surgical treatment of recurrent oral cavity carcinoma

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Trial Acronym

[---]*

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URL of the Trial

[---]*

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Brief Summary in Lay Language

For the treatment of relapse of your oral cavity cancer a surgical treatment is possible. To better investigate and improve the factors influencing the success of this treatment, we would evaluate the usual surgical procedure, the necessary routine diagnosis and the necessary part of your tumor aftercare.

Aim of the study:
In the present study, we want to analyze which patients with recurrence of oral cavity cancer especially benefits of the surgical treatment with regard to healing, Functionality and quality of life.

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Brief Summary in Scientific Language

The aim of this study is the evaluation of therapeutic success of a surgical relapse therapy.

Patients are included with a recurrence of OSCC and those which already had a radio/ chemoradiotherapy taken place. The Patient has be supplie a curative therapy approach of a surgical relapse therapy.

The intention is to evaluate whether and especially which kind of patients benefits significantly from a surgical treatment of recurrence in terms of overall and long-term survival.

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Organizational Data

  •   DRKS00009255
  •   2015/09/16
  •   [---]*
  •   yes
  •   Approved
  •   S-186/2015, Ethik-Kommission I der Medizinischen Fakultät Heidelberg
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Secondary IDs

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

  •   C00-C14 -  Malignant neoplasms of lip, oral cavity and pharynx
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Interventions/Observational Groups

  •   Surgical intervention:
    The therapy is based on the guidelines of the german community for maxillo-facial-surgery
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Characteristics

  •   Interventional
  •   [---]*
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Treatment
  •   Single (group)
  •   N/A
  •   No
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Primary Outcome

Time to death

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Secondary Outcome

1. Assessment of quality of life preoperatively, 6 months postoperatively and 12 months postoperatively based H & N35 and QLQ-C30 questionnaire.
2. Time to onset of recurrence histologically confirmed local recurrence (through regular follow-up examinations and control CT detected)
3. Time to occurrence of lymph node metastasis (through regular follow-up examinations and control CT detected)
4. Time to onset of distant metastasis (through regular follow-up examinations and control CT detected)
5. Tumor-related death

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2015/08/17
  •   60
  •   Monocenter trial
  •   National
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Inclusion Criteria

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

1. Written informed consent
2. Capacity to consent
3. Patients with histologically confirmed recurrence of squamous cell carcinoma of the oral cavity, which can be supplied on the basis of preoperative examination results of a curative surgical treatment.
4. General condition which enables a surgical treatment (ECOG≤2; Karnofsky Index > 50)

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Exclusion Criteria

1. Patients under 18 years
2. Poor general condition of the patient (ECOG≥2, Karnofsky-Index < 50%)

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Addresses

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    • Universitätsklinikum Heidelberg
    • Im Neuenheimer Feld 672
    • 69120  Heidelberg
    • Germany
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    • Klinik und Poliklinik für Mund-, Kiefer- und Gesichtschirurgie Universitätsklinikum Heidelberg
    • Mr.  Prof. Dr. Dr.  Kolia  Freier 
    • Im Neuenheimer Feld 400
    • 69120  Heidelberg
    • Germany
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    • Klinik und Poliklinik für Mund-, Kiefer- und Gesichtschirurgie Universitätsklinikum Heidelberg
    • Mr.  Sven Richard  Zittel 
    • Im Neuenheim Feld 400
    • 69120  Heidelberg
    • Germany
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Sources of Monetary or Material Support

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    • Klinik und Poliklinik für Mund-, Kiefer- und Gesichtschirurgie Universitätsklinikum Heidelberg
    • Mr.  Prof. Dr. Dr.  Kolia  Freier 
    • Im Neuenheimer Feld 400
    • 69120  Heidelberg
    • 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.