Trial document




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  DRKS00003164

Trial Description

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Title

Prospective, randomized and multicenter study for investigation of validity of the sentinel lymph node concept in patients with cervical cancer ≤ 2 cm

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Trial Acronym

SENCER

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URL of the Trial

[---]*

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Brief Summary in Lay Language

Aim of the present study is to show, if only removal of sentinel lymph nodes in women with early cervical
cancer leads to an equal overall survival compared to systematic radical pelvic lymphadenectomy and at
the same time is accompanied with considerable reduction of intra- and post operative complications.

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Brief Summary in Scientific Language

Aim of the present study is to show, if only removal of sentinel lymph nodes in women with early cervical
cancer leads to an equal overall survival compared to systematic radical pelvic lymphadenectomy and at
the same time is accompanied with considerable reduction of intra- and post operative complications.
We plan to randomize 1200 patients with histologically confirmed cervical cancer stage FIGO 1a1 L1 V0,
FIGO 1a2 L0 or L1 V0, FIGO1b1 L0 or L1 V0 ≤ 2 cm. In group A exclusively sentinel lymphadenectomy is
performed, in group B radical systematic pelvic lymphadenectomy is done. All the patients from both groups with tumor free
lymph nodes either radical hysterectomy or, in women seeking parenthood, radical trachelectomy is
performed. In all patients, if lymph nodes are tumor-involved systematic pelvic and paraaortic lymphadenectomy
followed by primary chemoradiation is recommended.
Primary end point is overall survival which should be equal for both groups. Secondary end point is periand
postoperative morbidity including quality of life, where a benefit for women with sentinellymphadenectomy
should be evident.

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Organizational Data

  •   DRKS00003164
  •   2011/07/05
  •   [---]*
  •   yes
  •   Approved
  •   EA1/207/09, Ethik-Kommission der Charité -Universitätsmedizin Berlin-
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Secondary IDs

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

  •   cervical cancer
  •   C53.9 -  Malignant neoplasm: Cervix uteri, unspecified
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Interventions/Observational Groups

  •   sentinel lymphadenectomy
  •   radical pelvic lymphadenectomy
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Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Single blind
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  •   Active control
  •   Treatment
  •   Parallel
  •   N/A
  •   [---]*
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Primary Outcome

Overall survival

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Secondary Outcome

Peri- and postoperative morbidity
Quality of life judged trough questionnaire EORTC QLQ C-30 (3 months after operation, then yearly till 4 year follow-up)
Recurrence-free survival

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Countries of Recruitment

  •   Germany
  •   Poland
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Locations of Recruitment

  • [---]*
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Recruitment

  •   Planned
  •   2011/09/01
  •   1200
  •   Multicenter trial
  •   International
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Inclusion Criteria

  •   Female
  •   18   Years
  •   80   Years
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Additional Inclusion Criteria

- Karnofsky-Index =/> 70,
- 18-80 year of age
- Cervical cancer diagnosed histologically
- FIGO 1a1 L1 V0, FIGO 1a2 L0 or L1 V0 FIGO 1b1 L0 or L1 V0 ≤ 2cm
- Signed informed consent form
- Patient's willing to cooperate

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Exclusion Criteria

- Neuroendocrine tumours or tumours of mixed type with neuroendocrine component
- Invasion of tumour cells in vascular system (V1)
- Pregnancy, breast feeding
- Distant metastases
- Previous malignant diseases
- History of pelvic radiotherapy
- Severe medical disorders
- Psychiatric diseases, that can interfere with participation and follow-up
- HIV infection or AIDS
- Drugs addiction
- Existing motoric or sensoric polyneuropathy > CTC Grad 1
- impossibility to perform anesthesia

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Addresses

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    • Charité Campus Charité Mitte
    • Charitéplatz 1
    • 10117  Berlin
    • Germany
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    • Klinik für Gynäkologie mit Onkologie Charité Campus Mitte
    • Mr.  Professor  Achim  Schneider 
    • Charitèplatz 1
    • 10117  Berlin
    • Germany
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    • Klinik für Gynäkologie mit Onkologie Charité Campus Mitte
    • Mr.  Dr.  Sergio  Frangini 
    • Charitèplatz 1
    • 10117  Berlin
    • Germany
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Sources of Monetary or Material Support

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    • Charité Campus Charité Mitte
    • Charitéplatz 1
    • 10117  Berlin
    • Germany
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Status

  •   Recruiting planned
  •   [---]*
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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.