Surgical Staging in Cervical Cancer Prior to Chemoradiation (uterus11)

January 14, 2010 updated by: Charite University, Berlin, Germany

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

250

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Germany
      • Berlin, Germany, 10117
        • Recruiting
        • Department of Gynaecology, Charité Campus Mitte und Benjamin Franklin
        • Contact:
        • Contact:
        • Principal Investigator:
          • Christhardt Köhler, Professor
        • Sub-Investigator:
          • Anja Dittgen
      • Berlin, Germany, 10117
        • Recruiting
        • Department of Radiooncology, Charité Campus Mitte und Campus Virchow
        • Contact:
        • Sub-Investigator:
          • Anja Dittgen
        • Contact:
        • Principal Investigator:
          • Simone Marnitz, PD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • 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 Names:
  • FIGO Staging

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
DFS (disease-free survival)
Time Frame: 4 years
4 years

Secondary Outcome Measures

Outcome Measure
Time Frame
OS, LC, QOL (overall survival, local control,quality of life, the determination of toxicity)
Time Frame: 4 years
4 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Charite University, Berlin, Germany

Collaborators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2009

Primary Completion (Anticipated)

April 1, 2013

Study Completion (Anticipated)

April 1, 2017

Study Registration Dates

First Submitted

January 13, 2010

First Submitted That Met QC Criteria

January 13, 2010

First Posted (Estimate)

January 14, 2010

Study Record Updates

Last Update Posted (Estimate)

January 15, 2010

Last Update Submitted That Met QC Criteria

January 14, 2010

Last Verified

August 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 108771

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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