Surgical Staging in Cervical Cancer Prior to Chemoradiation
Conditions
Cervical Cancer
Conditions: official terms
Uterine Cervical Neoplasms
Conditions: Keywords
Surgical Staging, Cervical Cancer, Chemoradiation, Outcome, Toxicity
Study Type
Interventional
Study Phase
N/A
Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: lymphadenectomy Type: Procedure
Name: Standard Staging Type: Other
Overall Status
Recruiting
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.
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 70 Years
Minimum Age: 18 Years
Gender: Female
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
Locations
Department of Gynaecology, Charité Campus Mitte und Benjamin Franklin
Berlin, Germany
Status: Recruiting
Contact: Christhardt Köhler, Professor - 004930450564091 - christhardt.koehler@charite.de
Department of Radiooncology, Charité Campus Mitte und Campus Virchow
Berlin, Germany
Status: Recruiting
Contact: Simone Marnitz, PD - 004930450527162 - simone.marnitz@charite.de
Start Date
April 2009
Completion Date
April 2017
Sponsors
Charite University, Berlin, Germany
Source
Charite University, Berlin, Germany
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page