Surgical Staging in Cervical Cancer Prior to Chemoradiation
NCT01049100 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 250
Last updated 2010-01-15
Summary
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.
Conditions
Interventions
- PROCEDURE
-
lymphadenectomy
paraaortal and pelvic lymphadenectomy laparoscopic or open
- 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
Sponsors & Collaborators
-
Deutsche Krebshilfe e.V., Bonn (Germany)
collaborator OTHER -
Arbeitsgemeinschaft Radiologische Onkologie
collaborator OTHER -
Charite University, Berlin, Germany
lead OTHER
Principal Investigators
-
Simone Marnitz, PD · Department of Radiooncology (Charité Campus Mitte und Virchow), Charitéplatz 1, 10117 Berlin, Germany
-
Christhardt Köhler, Prof. · Department of Gynaecology (Charité Campus Mitte und Benjamin Franklin), Charitéplatz 1, 10117 Berlin, Germany
-
Anja Dittgen · Department of Gynaecology (Charité Campus Mitte), Charitéplatz 1, 10117 Berlin, Germany
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 70 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2009-04-30
- Primary Completion
- 2013-04-30
- Completion
- 2017-04-30
Countries
- Germany
Study Locations
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