The Role of Micrometastasis and Isolated Tumor Cells (ITCs) in Endometrial and Cervical Cancer. A Multicenter Study.

Condition(s) studied

Investigational drug(s) / intervention(s)

Sentinel lymph node (SLN) biosy +/- lymphadenectomy: Evaluation of type and volume of lymph nodal disease

Study summary

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

Primary outcome measure(s)

• Survival (Disease free survival [DFS], overall survival [OS]) — through study completion, an average of 3 years
  Evaluation of survival outcomes according to the type and volume of lymph nodal disease
• Recurrence rate — through study completion, an average of 3 year
  Evaluation of incidence of recurrences (number of patients having a recurrence) according to the type and volume of lymph nodal disease

Trial sites (1)

More Fondazione IRCCS Istituto Nazionale dei Tumori, Milano trials in Italy

Other trials for the same condition