Trial document




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  DRKS00006068

Trial Description

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Title

Prospective randomized controlled trial to compare operative methods in early-stage cervical cancer

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Trial Acronym

SIMRA

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URL of the Trial

http://frauenklinik.charite.de/forschung_lehre/forschung/simra/

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Brief Summary in Lay Language

Nowadays, patients with early stage cervical cancer and the desire to have children have the opportunity to get a fertility sparing operation by radical trachelectomy. Thereby, the cervix and the surrounding tissue, the parametrium, are removed. Several studies demonstrated oncological safety. But half of the women getting pregnant after trachelectomy are suffered from preterm deliveries.
In other European countries, these patients with early cervical cancer get treated by removal of the tumor by conization (cone-shaped sample) only. The rate of preterm delivery is about 11%.
Until today there is no randomized controlled trial comparing both fertility sparing operation methods of simple conization versus radical trachelectomy in patients with early cervical cancer and the desire the have children.
In our study we are going to analyze the differences.

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Brief Summary in Scientific Language

SIMRA is prospective randomized controlled trial to compare two fertility preserving operative methods of simple conization (SC) and radical trachelectomy (RVT) in patients with early cervical cancer and the desire to have children.
The mean age of patients diagnosed with cervical cancer decreased within the last years. At the same time women in our country postpone childbearing in later years. Therefore, fertility preserving strategies for patients with early cervical cancer have found their way into German guidelines.
The RVT is a method removing the cervix and surrounding parametrium offered to women with cervical cancer of a tumour size of less than 2cm. RVT is difficult to perform technically and only few centers throughout Europe carry out the operation. Furthermore, the rate of preterm delivery is 50% after RVT. Alternatively patients are treated by tumour removal only (conization)in many countries in Europe.
After conization only 11% of patients will suffer from preterm delivery.
So far, there is no prospective, randomized trial comparing the fertility-preserving strategies.
Patients with early cervical cancer and the desire to have children are included. At first sentinel or pelvic lymphonodectomy by laparoscopy followed by frozen section analysis of the nodes are performed. The patients with negatives nodes will undergo a SC randomized in arm A and a RVT in arm B.
The recurrence rates within the two groups after 5 years observation time and the disease-free survival will be investigated, as well as the rate of preterm delivery, which is allegedly reduced after SC.

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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

  •   DRKS00006068
  •   2014/07/02
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  •   yes
  •   Approved
  •   EA1/356/13, Ethik-Kommission der Charité -Universitätsmedizin Berlin-
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Secondary IDs

  •   U1111-1158-7210 
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Health Condition or Problem studied

  •   C53 -  Malignant neoplasm of cervix uteri
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Interventions/Observational Groups

  •   Simple Conization
  •   Radical Vaginal Trachelectomy
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Open (masking not used)
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  •   Active control
  •   Treatment
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

Rates of Preterm Delivery
Follow-ups every 3 months postoperative for 2 years, after that every 6 months overall 5 years

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Secondary Outcome

Disease-free Survival
Peri- and Postoperative Complication Rates
Quality of Life
Overall survival
Marker of recurrence
Follow-ups every 3 months postoperative for 2 years, after that every 6 months overall 5 years

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2014/06/17
  •   200
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Female
  •   18   Years
  •   45   Years
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Additional Inclusion Criteria

Patients with cervical cancer, Squamous Cell Carcinoma and Adenocarcinoma
Cervical Cancer FIGO I (≥pT1a1 L1, to Ib1 < 2cm)
Desire to have children
Possibility to obtain informed consent

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Exclusion Criteria

Patients with multifocal tumours
Neuroendocrinological carcinoma / tumours
Invasion of small vessels (V1)
Pregnancy
History of other malignancies

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Addresses

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    • Klinik für GynäkologieCharité Campus Charité Mitte
    • Ms.  PD Dr. med.  Mandy  Mangler 
    • Charitéplatz 1
    • 10117  Berlin
    • Germany
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    • Klinik für GynäkologieCharité Campus Mitte
    • Ms.  PD Dr. med.  Mandy  Mangler 
    • Charitéplatz 1
    • 10117  Berlin
    • Germany
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    • Klinik für GynäkologieCharité Campus Charité Mitte
    • Ms.  Anne  Bartens 
    • Charitéplatz 1
    • 10117  Berlin
    • Germany
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Sources of Monetary or Material Support

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    • Charité - Universitätsmedizin Berlin
    • Cahritéplatz 1
    • 10117  Berlin
    • 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.