About this trial
The role of small-volume lymph node disease (ITC and micro metastases) among patients with endometrial or cervical cancer submitted to sentinel node (SLN) procedure is not clearly defined.
This study was designed to create a dataset of patients with lymph nodal disease. Data on type and volume of lymph nodal disease, therapeutic choices and oncological outcomes (DFS, OS, recurrence rate) will be collected and analyzed.
This will allow to define the groups of patients who may need or for whom it can be avoided any adjuvant treatment on the basis of lymph node status.
Eligibility criteria
Qualifiers
Early stage endometrial cancer scheduled for SLN procedure
Early stage cervical cancer scheduled for SLN procedure
Pathological evaluation of SLNs with standard ultra-staging or one-step nucleic acid amplification (OSNA) for the detection of metastasis
Presence of lymph nodes metastasis (macrometastasis or low volume disease [micrometastasis and isolated tumor cells])
Disqualifiers
Previous (<5 years) or concomitant malignancy other than non-melanoma skin cancer
Advanced/metastatic endometrial cancer
Locally advanced/metastatic cervical cancer
Trial design
Treatments tested in this trial
- Sentinel lymph node (SLN) biosy +/- lymphadenectomy