Sentinel Concept in Early Stage Cervical Cancer

Aim of present study is to inspect, if the removal alone of sentinel lymph nodes in women with early Cervix Carcinoma lead to, at equal length, overall survival like entire systematic dissection of lymph node and at the same time is accompanied with a considerably reduction of associated intra and post operative complications of lymph node dissection. For this purpose were randomized about 1200 patients with histological assured cervix carcinoma in stages FIGO 1a1 L1 V0, FIGO 1a2 L0 or L1 V0, FIGO1b1 L0 or L1 V0= 2 cm randomization. In the branch A takes place exclusively dissection sentinel lymph node, in the branch B takes place entire pelvic lymph node dissection. Afterwards takes place in tumor free lymph nodes the removal of uterus by a radical hysterectomy or, in presence of the wish of children, radical trachelectomy. In affected tumoural lymph nodes takes place systematic pelvic and peri aortic lymph node dissection followed by primary Radiochemotherapy. Primary end point is overall survival; this for both groups must be equal. Secondary end point is peri- and postoperative morbidity inclusive quality of life, the benefits for women must be evident with sentinel- lymph node dissection, don't have to show for both groups any significant difference.

Sex

Female

Minimum age

18 Years

Maximum age

70 Years

Inclusion Criteria:

* Karnofsky index
* Patients aged 18-70
* Histological assured cervix cancer (Squamous epithelium- or Adenoids cancer, adenosquamous cancer)
* Stadium FIGO from 1a1 L1 V0, FIGO 1a2 L0 or L1 V0, till FIGO 1b1 L0 or L1 V0 ≤ 2cm
* Completed and signed consent form
* Cooperation qualities of patients
* Performed explanation patients and written consent

Exclusion Criteria:

* Tumour thickness \> 2cm, FIGO- staging \> 1b1
* Neuroendocrine tumoural or mixed types with neuroendocrine tissues
* Tumoural invasion in vascular system (V1)
* Pregnancy, during lactation women without reliable contraception during radiochemotherapy
* Existing malignant diseases (Exception: basalioma of the skin)
* Radiotherapy of pelvis in anamnesis
* Severe internal associated diseases (Myocardial infarction, Heart pathology, Heart insufficiency NYHA III/IV, Severe chronic obstructive bronchopulmonary disease, kidney insufficiency, diabetes mellitus poorly regulated, uncontrolled infections) Anaesthesia not allowed
* Psychiatric diseases, which put off participating and after care
* HIV infection, or rather AIDS disease
* Drug addicted
* Precedent motorial or sensorial Polyneuropathies\>CTC grade 1

• RESULTAltgassen C, Hertel H, Brandstadt A, Kohler C, Durst M, Schneider A; AGO Study Group. Multicenter validation study of the sentinel lymph node concept in cervical cancer: AGO Study Group. J Clin Oncol. 2008 Jun 20;26(18):2943-51. doi: 10.1200/JCO.2007.13.8933. PMID 18565880