Prospective, randomized and multicenter study for investigation of validity of the sentinel lymph node concept in patients with cervical cancer = 2 cm
Not Applicable
- Conditions
- cervical cancerC53.9Cervix uteri, unspecified
- Registration Number
- DRKS00003164
- Lead Sponsor
- Charité Campus Charité Mitte
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Female
- Target Recruitment
- 1200
Inclusion Criteria
Karnofsky-Index =/> 70,
- 18-80 year of age
- Cervical cancer diagnosed histologically
- FIGO 1a1 L1 V0, FIGO 1a2 L0 or L1 V0 FIGO 1b1 L0 or L1 V0 = 2cm
- Signed informed consent form
- Patient's willing to cooperate
Exclusion Criteria
- Neuroendocrine tumours or tumours of mixed type with neuroendocrine component
- Invasion of tumour cells in vascular system (V1)
- Pregnancy, breast feeding
- Distant metastases
- Previous malignant diseases
- History of pelvic radiotherapy
- Severe medical disorders
- Psychiatric diseases, that can interfere with participation and follow-up
- HIV infection or AIDS
- Drugs addiction
- Existing motoric or sensoric polyneuropathy > CTC Grad 1
- impossibility to perform anesthesia
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method