Clinical trial NCT01157962: Sentinel Concept in Early Stage Cervical Cancer
Official title: Prospective, Randomized and Multicentre Study for Investigation of Valence of Sentinel Lymph Nodes Concept in Patients With Cervical Cancer ≤ 2 cm
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cervical Cancer
Keywords: Sentinel Concept
Lymphadenectomy
Early Stage Cervical Cancer
Overall Survive
Improvement Therapy
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
First posted: 2010-07-08
Enrollment: 1600
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: After randomization and assignment to experimental or control group lymphadenectomy is carried out.

Four different techniques can be used: 1) laparoscopic transperitoneal 2) laparoscopic retroperitoneal 3) open extraperitoneal 4) open transperitoneal. Radioactive labeling of sentinel-lymph nodes with 99technetium-marked colloid and/or patent blue is carried out. On the day prior to the operation 50mBq 99technetium or on the day of operation 10 mBq 99technetium is injected subepithelially in the cervix at 12, 3, 6 and 9 o'clock. Preoperatively 4 cc patent blue are injected in the same manner subepithelially. At the beginning of surgery parametrial tumor involvement, intrabdominal tumor dissemination, invasion of vesica-cervical and recto-vaginal septum are excluded. A lavage of cul-de-sac for cytological analysis is performed. The retroperitoneum is opened lateral of iliac vessels and blue colored lymph or radioactive nodes are removed. Sentinel- lymph node's radioactive signal is documented in counts per second (cps).

If no sentinel-lymph node is detected, complete pelvic lymph node dissection is carried out. If tumor involved pelvic lymph nodes are shown, paraaortic lymph node dissection is carried out. If sentinel- or pelvic lymph nodes are quoted as tumor free at frozen sections, radical hysterectomy or radical trachelectomy is performed. Radical hysterectomy follows in an extension a type-2 variation. In patients with positive lymph nodes in frozen section or in definitive histo-pathology primary chemoradiation is performed.

Eligibility criteria: 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

Primary outcomes:
measure: overall survival
timeFrame: one year
Secondary outcomes:
measure: morbidity
timeFrame: one year
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Charite University of Berlin
Study officials:
References:
citation: Altgassen 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.