Surgical Staging in Cervical Cancer Prior to Chemoradiation

Not Applicable

• Conditions: Cervical Cancer
• Interventions: Procedure: lymphadenectomy; Other: Standard Staging

• Registration Number: NCT01049100
• Lead Sponsor: Charite University, Berlin, Germany

Brief 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.

Study Timeline

• Study Start: 2009-04
• Status Verified: 2009-08
• Study First Submitted: 2010-01-13
• Study First Submitted QC: 2010-01-13
• Study First Posted: 2010-01-14
• Last Update Submitted: 2010-01-14
• Last Update Posted: 2010-01-15
• Primary Completion: 2013-04
• Study Completion: 2017-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 250

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
operative staging (A)	lymphadenectomy	operative staging and systemic lymphadenectomy, paraaortal and pelvine, laparoscopic or open
Standard (B)	Standard Staging	No surgical intervention. Clinical Staging (FIGO) CT Abdomen / pelvic enlarged or suspicious lymphnodes--\> CT controlled biopsy and histological analysis.

Primary Outcome Measures

Name	Time	Method
DFS (disease-free survival)	4 years

Secondary Outcome Measures

Name	Time	Method
OS, LC, QOL (overall survival, local control,quality of life, the determination of toxicity)	4 years

Trial Locations

Locations (2)

Department of Gynaecology, Charité Campus Mitte und Benjamin Franklin; 🇩🇪 Berlin, Germany

Department of Radiooncology, Charité Campus Mitte und Campus Virchow; 🇩🇪 Berlin, Germany