Surgical Staging in Cervical Cancer Prior to Chemoradiation

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Cervical Cancer

Intervention / Treatment
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* Procedure: lymphadenectomy
* Other: Standard Staging


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: operative staging (A)<br>operative staging and systemic lymphadenectomy, paraaortal and pelvine, laparoscopic or open | Procedure: lymphadenectomy<br>* paraaortal and pelvic lymphadenectomy laparoscopic or open<br>* Other names: debulking, surgical staging;|
| No Intervention: Standard (B)<br>No surgical intervention. Clinical Staging (FIGO) CT Abdomen / pelvic enlarged or suspicious lymphnodes--> CT controlled biopsy and histological analysis. | Other: Standard Staging<br>* 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<br>* Other names: FIGO Staging;|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Surgical Staging, Cervical Cancer, Chemoradiation, Outcome, Toxicity