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Surgical Staging in Cervical Cancer Prior to Chemoradiation (uterus11)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified August 2009 by Charite University, Berlin, Germany.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01049100
First Posted: January 14, 2010
Last Update Posted: January 15, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Deutsche Krebshilfe e.V., Bonn (Germany)
Arbeitsgemeinschaft Radiologische Onkologie
Information provided by:
Charite University, Berlin, Germany
January 13, 2010
January 14, 2010
January 15, 2010
April 2009
April 2013   (Final data collection date for primary outcome measure)
DFS (disease-free survival) [ Time Frame: 4 years ]
Same as current
Complete list of historical versions of study NCT01049100 on ClinicalTrials.gov Archive Site
OS, LC, QOL (overall survival, local control,quality of life, the determination of toxicity) [ Time Frame: 4 years ]
Same as current
Not Provided
Not Provided
 
Surgical Staging in Cervical Cancer Prior to Chemoradiation
Prospective, Randomised and Multi-centric Therapy Optimisation Study for Examining the Influence of Surgical Staging on the Oncological Results for Patients With Cervix Carcinoma of the FIGO Stages IIB-IV After Chemoradiation
The aim of this study is to determine whether the modified therapy on the basis of operative staging and systematic, pelvine and paraaortal lymphadenectomy for patients with cervical cancer of the FIGO stages IIB-IV prior to introducing radio-chemotherapy leads to a significant improvement of disease-free survival.

The aim of this study is to determine whether the modified therapy on the basis of operative staging and systematic, pelvine and paraaortal lymphadenectomy for patients with cervical cancer of the FIGO stages IIB-IV prior to introducing radio-chemotherapy leads to a significant improvement of disease-free survival.

To this end, 250 patients with histologically verified cancer of the cervix uteri of the stages IIB-IV shall be randomised to a standard arm (ARM B), whereby the therapy shall be conducted on the basis of the clinical FIGO stage.

The patients randomised to the test arm (Arm A), after determining the clinical FIGO stage, shall initially receive an operative staging in the form of a pelvine paraaortal lymphadenectomy (laparoscopic or open). On the basis of the operatively obtained findings, a ("surgically") modified tumour stage shall be determined. This "surgical" tumour stage, which shall take into account the affection of the lymph nodes, the infiltration of the neighbouring organs and the intraperitoneal spread, shall serve as the basis for the execution of primary, combined radio-chemotherapy. The primary end-point is the disease-free survival of both groups, the secondary endpoints are overall survival, the local control of both groups, as well as the determination of toxicity and the quality of life.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Cervical Cancer
  • Procedure: lymphadenectomy
    paraaortal and pelvic lymphadenectomy laparoscopic or open
    Other Name: debulking, surgical staging
  • Other: Standard Staging
    clinical Staging (FIGO) (examination in narcosis, biopsy, cystoscopy, rectoscopy) X-Ray Radiograph of Thorax, Ultrasound of abdomen, CT abdomen / pelvis positive, suspicious lymphnodes--> CT controlled biopsy
    Other Name: FIGO Staging
  • Experimental: operative staging (A)
    operative staging and systemic lymphadenectomy, paraaortal and pelvine, laparoscopic or open
    Intervention: Procedure: lymphadenectomy
  • No Intervention: Standard (B)
    No surgical intervention. Clinical Staging (FIGO) CT Abdomen / pelvic enlarged or suspicious lymphnodes--> CT controlled biopsy and histological analysis.
    Intervention: Other: Standard Staging

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
250
April 2017
April 2013   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Karnofsky-Index =/> 70,
  • age between 18 - 70 years
  • histological assured cervical cancer (by biopsy)
  • FIGO stages II B - IV
  • written informed consent
  • patient's ability to cooperate

Exclusion Criteria:

  • neuroendocrine tumors or histological mixed types containing neuroendocrine fractions
  • pregnancy, lactation,
  • distant metastases, except paraaortal metastases
  • other malignant diseases in anamnesis
  • pelvic radiotherapy in anamnesis
  • severe internal diseases
  • psychiatric diseases which might query the trial attendance or follow-up
  • HIV-Infection or AIDS
  • drug addiction
  • existing motoric or sensoric polyneuropathy > CTC Grad 1
Sexes Eligible for Study: Female
18 Years to 70 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
 
NCT01049100
108771
Yes
Not Provided
Not Provided
PD Dr. med. Simone Marnitz / Prof. Dr. med. Christhardt Köhler, Department of Radiooncology (Charité Campus Mitte und Virchow) / Department of Gynaecology (Charité Campus Mitte und Benjamin Franklin)
Charite University, Berlin, Germany
  • Deutsche Krebshilfe e.V., Bonn (Germany)
  • Arbeitsgemeinschaft Radiologische Onkologie
Study Chair: Simone Marnitz, PD Department of Radiooncology (Charité Campus Mitte und Virchow), Charitéplatz 1, 10117 Berlin, Germany
Study Chair: Christhardt Köhler, Prof. Department of Gynaecology (Charité Campus Mitte und Benjamin Franklin), Charitéplatz 1, 10117 Berlin, Germany
Principal Investigator: Anja Dittgen Department of Gynaecology (Charité Campus Mitte), Charitéplatz 1, 10117 Berlin, Germany
Charite University, Berlin, Germany
August 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP