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

ConditionsEndometrial CancerCervical CancerSentinel Lymph NodeMicrometastasisSentinel Lymph Node BiopsyEndometrium TumorEndometrial NeoplasmsCervical NeoplasmCervical TumorLymph Node MetastasesLymph Node Disease
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorFondazione IRCCS Istituto Nazionale dei Tumori, Milano

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

This trial does not accept healthy volunteers

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 population

Patients with early stage uterine (endometrial or cervical) cancer, who underwent a sentinel lymph node (SLN) procedure with an identification of lymph nodes metastasis (macrometastasis or low volume disease \[micrometastasis and isolated tumor cells\])

Trial design

Design model

Cohort

Time perspective

Retrospective

Treatments tested in this trial

  • Sentinel lymph node (SLN) biosy +/- lymphadenectomy

    Procedure/Surgery

    Evaluation of type and volume of lymph nodal disease

Treatment groups

500 Participants
are divided into 2 treatment groups
Group A: Endometrial cancer patients1 intervention
Group B: Cervical cancer patients1 intervention

Trial outcomes

Primary outcomes

1

Survival (Disease free survival [DFS], overall survival [OS])

Evaluation of survival outcomes according to the type and volume of lymph nodal disease

Time frame
through study completion, an average of 3 years
2

Recurrence rate

Evaluation of incidence of recurrences (number of patients having a recurrence) according to the type and volume of lymph nodal disease

Time frame
through study completion, an average of 3 year

Secondary outcomes

1

Usage of adjuvant therapy in case of small-volume lymph node disease

Evaluation of the number of patients receiving or not receiving an adjuvant treatment (radiation therapy, chemotherapy, combinations of the two) in case of small-volume lymph node disease (ITC and micro metastasis)

Time frame
through study completion, an average of 6 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

Lead sponsor

Source ClinicalTrials.gov
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