Status:
UNKNOWN
Sentinel Concept in Early Stage Cervical Cancer
Lead Sponsor:
Charite University, Berlin, Germany
Conditions:
Cervical Cancer
Eligibility:
FEMALE
18-70 years
Phase:
NA
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 ly...
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 retroperiton...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2018
Estimated Enrollment :
1600 Patients enrolled
Trial Details
Trial ID
NCT01157962
Start Date
January 1 2010
End Date
January 1 2018
Last Update
July 1 2011
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Charite University of Berlin
Berlin, State of Berlin, Germany, 10117