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

Recruiting

• Conditions: Endometrial Cancer; Sentinel Lymph Node; Endometrial Neoplasms; Cervical Cancer; Cervical Neoplasm; Lymph Node Metastases; Micrometastasis; Sentinel Lymph Node Biopsy; Endometrium Tumor; Cervical Tumor
• Interventions: Procedure: Sentinel lymph node (SLN) biosy +/- lymphadenectomy

• Registration Number: NCT04403867
• Lead Sponsor: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-01-02
• Study First Submitted: 2020-05-18
• Study First Submitted QC: 2020-05-21
• Study First Posted: 2020-05-27
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-15
• Last Update Posted: 2022-08-17
• Primary Completion: 2025-01
• Study Completion: 2027-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 500

Inclusion Criteria

• 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])

Exclusion Criteria

• Previous (<5 years) or concomitant malignancy other than non-melanoma skin cancer
• Advanced/metastatic endometrial cancer
• Locally advanced/metastatic cervical cancer

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cervical cancer patients	Sentinel lymph node (SLN) biosy +/- lymphadenectomy	Patients submitted to Sentinel Lymph Node (SLN) procedure. Patients with lymph nodal disease (macrometastasis, micrometastasis, isolated tumor cells).
Endometrial cancer patients	Sentinel lymph node (SLN) biosy +/- lymphadenectomy	Patients submitted to Sentinel Lymph Node (SLN) procedure. Patients with lymph nodal disease (macrometastasis, micrometastasis, isolated tumor cells).

Primary Outcome Measures

Name	Time	Method
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
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

Secondary Outcome Measures

Name	Time	Method
Usage of adjuvant therapy in case of small-volume lymph node disease	through study completion, an average of 6 months	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)

Trial Locations

Locations (1)

Fondazione IRCCS Istituto Nazionale dei Tumori; 🇮🇹 Milan, Italy