Pretherapeutic surgical staging of para-aortic lymph nodes in advanced stage uterine cervical cancer.
- Conditions
- Advanced stage uterine cervical cancer, surgical staging, para-aortic lymph node metastasesGevorderd cervixcarcinoom, chirurgisch stadiëren, para aortale lymfklier metastasen
- Registration Number
- NL-OMON28637
- Lead Sponsor
- Radboudumc
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 30
Inclusion Criteria
Age > 18 years
-Histological confirmed squamous cell, adenosquamous or adenocarcinoma of the cervix
Exclusion Criteria
-Previous malignancy (except for non-melanoma skin cancer)
-Prior retroperitoneal surgery
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method -Proportion of included patients amongst all eligible patients.<br /> <br>-Duration of surgical procedure<br /><br>-Blood loss<br /><br>-Complications<br /><br>-(serious) Adverse events<br /><br>-Nodal yield
- Secondary Outcome Measures
Name Time Method Data on sensitivity, specificity, negative and positive predictive value for a future independent phase 3 trial.<br><br /><br /><br>Number and diameter of metastases and proportion of modified initial treatment plans due to histological findings. <br><br /><br /><br>Morbidity and mortality, Quality of life and progression-free and overall survival during the first year after surgery.<br><br /><br /><br>Treatment delay due to surgical intervention and histological analyses.