Health TrialsbyHealthPanel

Sentinel Node Mapping in High Risk Endometrial Cancer

ConditionsEndometrial CancerLymph Node Metastases
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-75
SponsorAC Camargo Cancer Center

About this trial

This study will evaluate the role of systematic lymphadenectomy after sentinel node (SLN) mapping in high risk endometrial cancer (high grade histologies or deep myometrial invasion). The participants will be randomized in a non-inferiority controlled trial in 2 groups: SLN mapping or SLN mapping followed by systematic lymphadenectomy.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

High grade histologies (endometrioid grade 3, serous, clear cell and carcinosarcoma)

Endometrioid grades 1 or 2 with myometrial invasion of ≥50%

Endometrioid grades 1 or 2 with cervical invasion

Clinically suitable to receive systematic lymphadenectomy

Disqualifiers

Previous hysterectomy in other institution

Presence of extra-uterine disease (peritoneal, visceral or suspicious lymph node metastasis)

Previous pelvic node dissection

Trial design

Design model

Parallel

Treatments tested in this trial

  • Sentinel Node Mapping

    Procedure/Surgery

    At least one sentinel node should be retrieved in both hemipelvis. If no sentinel node is found in one hemipelvis, a side specific lymphadenectomy will be performed.

  • Lymphadenectomy

    Procedure/Surgery

    Systematic Pelvic and Para-Aortic Lymphadenectomy

Treatment groups

178 Participants
are divided into 2 treatment groups
Group A: Sentinel Node Mapping plus LymphadenectomyActive comparator 2 interventions
Group B: Sentinel Node MappingExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Recurrence

Recurrence Free Survival

Time frame
3 years

Secondary outcomes

1

Survival

Overall Survival

Time frame
5 years
2

Early morbidity

Surgical and clinical morbidity

Time frame
<30 days after surgery
3

Late morbidity

Surgical and clinical morbidity

Time frame
>30 days after surgery
4

Lymphedema

Presence and lymphedema graduation

Time frame
Evaluation before surgery and after 6 and 12 months of follow-up

Other outcomes

Sponsors and contacts

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

AC Camargo Cancer Center

Lead sponsor

Source ClinicalTrials.gov
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