Surgical Staging in Cervical Cancer Prior to Chemoradiation

NCT01049100 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 250

Last updated 2010-01-15

No results posted yet for this study

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

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01049100 on ClinicalTrials.gov