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Surgical Staging in Cervical Cancer Prior to Chemoradiation (uterus11)

This study is currently recruiting participants.
Verified August 2009 by Charite University, Berlin, Germany
Sponsor:
Collaborators:
Deutsche Krebshilfe e.V., Bonn (Germany)
Arbeitsgemeinschaft Radiologische Onkologie
Information provided by:
Charite University, Berlin, Germany
ClinicalTrials.gov Identifier:
NCT01049100
First received: January 13, 2010
Last updated: January 14, 2010
Last verified: August 2009
History of Changes
  Purpose

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.


Condition Intervention
Cervical Cancer
 Procedure: lymphadenectomy
Other: Standard Staging

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Charite University, Berlin, Germany:

Primary Outcome Measures:
  • DFS (disease-free survival) [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • OS, LC, QOL (overall survival, local control,quality of life, the determination of toxicity) [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 250
Study Start Date: April 2009
Estimated Study Completion Date: April 2017
Estimated Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: operative staging (A)
operative staging and systemic lymphadenectomy, paraaortal and pelvine, laparoscopic or open
 Procedure: lymphadenectomy
paraaortal and pelvic lymphadenectomy laparoscopic or open
Other Name: debulking, surgical staging
No Intervention: Standard (B)
No surgical intervention. Clinical Staging (FIGO) CT Abdomen / pelvic enlarged or suspicious lymphnodes--> CT controlled biopsy and histological analysis.
 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

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01049100

Contacts
Contact: Simone Marnitz, PD 004930450627162 simone.marnitz@charite.de

Locations
Germany
Department of Gynaecology, Charité Campus Mitte und Benjamin Franklin Recruiting
Berlin, Germany, 10117
Contact: Christhardt Köhler, Professor     004930450564091     christhardt.koehler@charite.de    
Contact: Anja Dittgen     004930450664434     anja.dittgen@charite.de    
Principal Investigator: Christhardt Köhler, Professor            
Sub-Investigator: Anja Dittgen            
Department of Radiooncology, Charité Campus Mitte und Campus Virchow Recruiting
Berlin, Germany, 10117
Contact: Simone Marnitz, PD     004930450527162     simone.marnitz@charite.de    
Contact: Anja Dittgen     004930450664434     anja.dittgen@charite.de    
Principal Investigator: Simone Marnitz, PD            
Sub-Investigator: Anja Dittgen            
Sponsors and Collaborators
Charite University, Berlin, Germany
Deutsche Krebshilfe e.V., Bonn (Germany)
Arbeitsgemeinschaft Radiologische Onkologie
Investigators
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
  More Information

Additional Information:
Websites of the Association of Gynecological Cancer and Society of Radiooncology, Germany  This link exits the ClinicalTrials.gov site
Association for Radiooncology  This link exits the ClinicalTrials.gov site

Publications:

Responsible Party: 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)
ClinicalTrials.gov Identifier: NCT01049100     History of Changes
Other Study ID Numbers: 108771
Study First Received: January 13, 2010
Last Updated: January 14, 2010
Health Authority: Germany: Federal Office for Radiation Protection

Keywords provided by Charite University, Berlin, Germany:
Surgical Staging
Cervical Cancer
Chemoradiation
Outcome
Toxicity

Additional relevant MeSH terms:
Uterine Cervical Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
 Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female

ClinicalTrials.gov processed this record on May 19, 2013