Trial document



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  DRKS00013041

Trial Description

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Title

Prospective evaluation of disease free survival and Quality of Life following microvascular reconstruction in early oral squamous cell carcinoma

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Trial Acronym

PROCURE

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URL of the Trial

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Brief Summary in Lay Language

This study aims to evaluate the Quality of life and therapeutic success in patients with early stage oral cancer who are treated via Tumor resection and reconstruction using microvascular transplants. For this purpose, clinical follow up including Quality of life-surveys and additionally MRI-3D-Imaging will take place in an interval of 3, 6, 12, 18 and 24 months following Primary surgery.

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Brief Summary in Scientific Language

The purpose of this prospective, monocentric study is to evaluate the Quality of life and therapeutic success in Terms of disease free survival in patients with early stage oral cancer and clinically negative cervical lymph node status (c2 T1/2 N0 M0) who are treated via Tumor resection and reconstruction using autologous microvascular transplants. Follow up will include clinical examination in a monthly scale and Survey for Quality of life (using QLQ-C30 and QLQ-H&N35) in combination with MRI for detection of disease recurrence 3, 6, 12, 18 and 24 months following Primary surgery.

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Do you plan to share individual participant data with other researchers?

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Description IPD sharing plan:

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Organizational Data

  •   DRKS00013041
  •   2017/09/19
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  •   yes
  •   Approved
  •   S-414/2017, Ethik-Kommission I der Medizinischen Fakultät Heidelberg
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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

  •   Surgical therapy following current therapeutical Guidelines (Tumor removal and reconstruction using autologous microvascular transplants). Regular clinical follow up every month and MRI (head and neck) for detection of disease recurrence 3, 6, 12, 18 an 24 months after Primary therapy. Quality of life Survey (QLQ-C30 and QLQ-H&N35) 3, 6, 12, 18 and 24 months following Primary therapy.
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Characteristics

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

Disease free survival (DFS) for 24 months following Primary therapy evaluated by regular clinical and MRI examinations

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Secondary Outcome

Postoperative Quality of Life (QLQ-C30 and QLQ-H&N35) 3, 6, 12, 18 and 24 months after Primary therapy in comparison to baseline.
Tumorrelated cause of death

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
  • University Medical Center 
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Recruitment

  •   Actual
  •   2017/10/01
  •   50
  •   Multicenter trial
  •   National
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Inclusion Criteria

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

Squamous cell carcinoma of the oral cavity with T-Stage T1 or T2 and clinically negative neck node Status (cN0)

Surgical Treatment via Tumor resection, Neck Dissection and microvacular reconstruction

Minimum Age: 18 years

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Exclusion Criteria

Recurrence of Prior oral squamous cell carinoma
Lack of understanding or legal Age for written consent

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Addresses

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    • Klinik und Poliklinik für Mund-, Kiefer- und GesichtschirurgieKopfklinikUniversitätsklinikum Heidelberg
    • Mr.  Prof. Dr. Dr.   Christian  Freudlsperger 
    • Im Neuenheimer Feld 400
    • 69120  Heidelberg
    • Germany
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    • Klinik und Poliklinik für Mund-, Kiefer- und GesichtschirurgieKopfklinikUniversitätsklinikum Heidelberg
    • Mr.  Prof. Dr. Dr.   Christian  Freudlsperger 
    • Im Neuenheimer Feld 400
    • 69120  Heidelberg
    • Germany
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    • Klinik und Poliklinik für Mund-, Kiefer- und GesichtschirurgieKopfklinikUniversitätsklinikum Heidelberg
    • Mr.  Dr. med. Dr. med. dent.  Julius  Moratin 
    • Im Neuenheimer 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, Kopfklinik,Universitätsklinikum Heidelberg
    • 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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