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Prospective, Randomized and Multicentre Study for Investigation of Valence of Sentinel Lymph Nodes Concept in Patients With Cervical Cancer ≤ 2 cm

18 Years
70 Years
Open (Enrolling)
Cervical Cancer

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Trial Information

Prospective, Randomized and Multicentre Study for Investigation of Valence of Sentinel Lymph Nodes Concept in Patients With Cervical Cancer ≤ 2 cm

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.

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

- 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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Outcome Measure:

overall survival

Outcome Description:

Primary study end point is that overall survival of patients with sentinel-concept, has not to differentiate from that one of patients with systematic lymph node dissection.

Outcome Time Frame:

one year

Safety Issue:



Germany: Ethics Commission

Study ID:




Start Date:

January 2010

Completion Date:

January 2018

Related Keywords:

  • Cervical Cancer
  • Sentinel Concept
  • Lymphadenectomy
  • Early Stage Cervical Cancer
  • Overall Survive
  • Improvement Therapy
  • Uterine Cervical Neoplasms