Cervical Cancer
Conditions
Keywords
Surgical Staging, Cervical Cancer, Chemoradiation, Outcome, Toxicity
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.
Interventions
PROCEDURElymphadenectomy
paraaortal and pelvic lymphadenectomy laparoscopic or open
OTHERStandard 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
Deutsche Krebshilfe e.V., Bonn (Germany)
Arbeitsgemeinschaft Radiologische Onkologie
Charite University, Berlin, Germany
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| DFS (disease-free survival) | 4 years |
Secondary
| Measure | Time frame |
|---|---|
| OS, LC, QOL (overall survival, local control,quality of life, the determination of toxicity) | 4 years |
Countries
Germany
Contacts
Primary ContactSimone Marnitz, PD
Outcome results
None listed